Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical needValneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 750 employees.

Job Summary

To undertake microbiological tasks and analysis for the release and monitoring of facilities, raw materials, intermediate and final product samples according to defined procedures and protocols, in accordance with regulatory requirements.

Responsibilities:

  • Execute microbiological procedures for testing of raw materials, intermediate products and final product samples, according to defined SOPs and protocols
  • Perform environmental monitoring of cleanroom areas as required, to support manufacturing processes and Facility Contamination Control (FCC)
  • Conduct all activities in a careful and safe manner and in full compliance with HSE requirements
  • Ensure that all required training is complete in procedures performed and operate in compliance with regulatory requirements
  • Adhere to 5S working practices. Identify and implement areas for continuous improvement and escalate to Line Manager
  • Immediately escalate and report any deviations to materials, facilities, processes or procedures to line manager
  • Maintain all QC systems, databases, logs and support the generation of QC trend data
  • Be accountable for QC areas being clean, tidy and well organised and in a state of continuous inspection readiness
  • Ensure that equipment, facilities and materials used in the QC laboratories comply with defined standards
  • Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team setting
  • Undertake any other duties in accordance with company requirements
  • Undertake shift work and/or support activities that require to be performed out of normal business hours, when requested, to support business priorities

Experience:

  • Degree in biological sciences or relevant experience
  • Knowledge of GMP guidelines and regulatory body requirements
  • Experience of microbiological methods in a production-focused environment including but not limited to; Total Viable Count, Bacterial Endotoxin, Environmental monitoring, Microbial Identification and Growth Promotion
  • Minimum of 1 Year relevant Industry Experience
  • Biologics / vaccine background ideal
  • Experience of Quality Management Systems
  • Experience of working to deadlines and managing conflicting priorities
  • Experience managing external relationships for effective delivery, e.g. vendors, test houses

Skills:

  • Ability to organise, deliver planned schedules and work across QC, Process Development and QA
  • Experience of writing QMS documentation, e.g. SOPs, Deviations, Change Controls, CAPA desired
  • Excellent time management and prioritisation skills
  • Ability to communicate at all levels within and outside QC
  • Ability to contribute effectively to successful teamwork, and work independently and manage own workload when required

Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical needValneva has leveraged its expertise and capabilities both to successfully commercialise two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19. 

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 750 employees.

An opportunity has arisen at Valneva Scotland for a Buyer within the SCM Procurement Department.

Job Summary

The Buyer will work in association with their team in ensuring that all materials, equipment and services is procured in line with quality and regulatory expectations, with the most favourable commercial terms and in line with the Company procedures.

Responsibilities

  • End to end procurement, including contract & supplier management
  • Purchase goods, materials and services from approved suppliers and in line with defined Company SOPs and protocols
  • Secure the most favourable terms in regards to cost, quality, guarantee of delivery and continuity of supply
  • Negotiate and improve prices and terms of business with suppliers continuously reviewing opportunities to make tangible savings and improve on commercial terms
  • Manage purchase orders on the company ERP system.
  • Contact suppliers to resolve price, delivery timelines, quality or invoice issues
  • Communicate and monitor any supply and/or service issues which may impact the business operations in a timely manner
  • Work cross functionally and collaboratively to improve the performance of existing suppliers and escalate as appropriate poor performance and alternative routes of supply
  • Ensure that a professional and consistent approach is taken with all internal and external relationships
  • Communicate in a consistent and professional manner
  • Compile data and reports relating to supplier performance and to enable evaluation
  • Ensure training and QMS are up to date in a timely manner.
  • Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team setting
  • To undertake any other duties as requested by the line manager in accordance with company requirements

Experience

  • Relevant work experience in a procurement role within a manufacturing environment; experience of working in a GMP environment would be advantageous but not essential
  • Knowledge and experience of working with a quality management system
  • Experience working within a procurement team managing a supply chain with a portfolio of complex products identifying and mitigating areas of risk
  • CIPS knowledge and understanding would be beneficial but not essential
  • Experience of working closely and collaboratively with suppliers
  • Computer literate (Microsoft Office)

Required Skills

  • Team player
  • Able to build and maintain effective a collaborative relationships with internal and external stakeholders
  • Good communication and written skills
  • Commercial awareness with an understanding of how failure impacts the business operation
  • Able to manage time effectively, focus and prioritise critical tasks and to achieve set targets
  • Able to work well under pressure
  • Familiarity with an integrated Enterprise Resource Planning (ERP) system would be beneficial
  • Self-motivated, energetic and value driven
  • Desire to develop and grow as the company expands

For the right candidate there will be training and development opportunities to maximise your ability to succeed in this role and advance your career with Valneva.

Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical needValneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19. 

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

Are you a forward thinker with exceptional leadership skills? Do you have a background as a HS Manager and thrive in getting the best out of the people you work with? If so, we’d love to hear from you!

The Role

We have a wonderful opportunity for a Health & Safety Manager to support our organisational safety strategy, overseeing H&S policies and regulations to ensure they are fully adhered to as we move forward with our vaccine manufacturing. You will continually strive to ensure Valneva meets its statutory obligations in all areas pertaining to health, safety, and welfare at work.

You would be responsible for (but not limited to):

  • Working with and training all employees to manage, monitor and improve the health and safety standards in the workplace
  • Working with the Head of Facility Management to ensure requirements for; Building regulations, fire safety, electrical safety, contractors permit to work systems, Legionella and pressure systems regulations are complied with
  • Ensure that all accidents, incidents and near hits are documented, investigated and recommended improvements implemented
  • Establish a structured health and safety system in compliance with health and safety legislation
  • Keep up to date with all aspects of relevant health, safety & welfare at work legislation and communicate relevant changes to the business
  • Provide regular reports to the Human Resources Director, Executive Management Team and Senior Management Team on relevant health and safety activities

What we’re looking for:

The ideal HSE Manager will come from a STEM background and possess relevant health and safety experience within the biopharmaceutical manufacturing industry or other related industries, as well as a post graduate qualification in Health and Safety (NEBOSH Diploma, NVQ Level 5 Diploma).

Previous line management experience is advantageous. Above all, you will possess exceptional relationship and developmental skills, and will have a track record of promoting a safe working culture within your organisation.

Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical needValneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

We have immediate openings within our Engineering Team to join at Technician Level, with openings for a variety of skillsets including Mechanical, Electrical, Calibration and Validation. These will be 12 hour shift based roles supporting with our 24/7 Manufacturing Schedule

Your role will be to execute defined, trained engineering procedures for maintenance, qualification, validation and calibration of equipment / facility, in compliance with applicable cGMP standards, regulations, techniques, best practice and business metrics.

Responsibilities

  • Maintain safe and available systems through supervision and execution of equipment, plan and facilities maintenance, qualifications, validation and calibration ensuring compliance defined by SOPs, protocols and procedures
  • Apply cGMP / GEP work practices and techniques in compliance with regulatory requirements
  • Immediately escalate and report any deviations to materials, facilities, processes or procedures
  • Collaborate with internal customers ensuring clear communication on planned and unplanned actions ensuring due consideration of access, supervision, documentation, safety product quality or regulatory compliance
  • Be accountable for engineering areas being clean, tidy and well organised and in a state of continuous inspection readiness
  • Maintain engineering records, logs and documentation in a compliant manner
  • Deliver actions required to ensure progression of investigations, deviations, change controls and CAPAs to agreed timescales
  • Conduct all activities in a careful and safe manner and in full compliance with HSE requirements ensuring that at any time equipment, facilities and materials used in the area of responsibility comply with defined standards
  • Actively contribute to the development and maintenance of enthusiastic, supportive and collaborative environment within the team setting, identifying areas for continuous improvement to the respective manager
  • Shift work and out of hours work as required
  • To undertake any other duties as requested by the line manager in accordance with company requirements

Experience

  • HNC/ONC or equivalent experience in relevant engineering discipline
  • Relevant work experience in a GMP environment
  • Experience in GMP document preparation, process execution, recording data and report writing
  • Experience of co-ordinating equipment / facilities maintenance
  • Experience in the management of environmental, health and safety issues, including permits to work
  • Knowledge of Good Engineering Practice and process improvement tools such as six sigma, lean, FMEA etc

Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical needValneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19. 

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

Are you an experienced QP? Or just starting out on your journey, with a good understanding and working knowledge of the Pharmaceutical Industry? We would welcome an opportunity to speak with you further.

With responsibility for performing the legal and routine duties with respect to the review, approval and certification of licensed and investigational products.  To maintain effective quality oversight of internal and external contract manufacturing and testing activities in order to verify that local and Global Quality Systems/procedures are defined, being adhered to, are operating effectively and comply with UK, EU, FDA, RoW regulatory requirements.

Our successful Qualified Person would be someone possessing relevant experience of UK, EU and FDA cGMP requirements for the manufacturing and testing of biopharmaceutical products in a commercial environment.

Key Responsibilities

  • To perform the legal and routine duties of a QP with respect to the review, approval and certification of licensed and investigational products; as defined in article 51 of Directive 2001/83/EC (as amended by Directive 2004/27/EC) and described in Annex 16 of the EU Guide to GMP
  • To represent the company to external authorities on liaison with MHRA, FDA, EMEA CAs and OMCLs on; product defect reporting, recall and Inspection related matters (all interactions must be aligned with Regulatory Affairs)
  • To advise the Director of Quality Operations on any matters arising which impact on supplier or service provider status or the import of bulk product into EU, or release of final product for use in the UK/EU and its export from the EU
  • To manage the batch disposition process, comprising batch document review and approval and batch certification file compilation. Make quality assessments on released products subject to temperature excursions and communicate to customers
  • To ensure the systems and processes for the management of Product Technical Complaints and Product Recalls are being conducted in accordance with the licensed risk management and pharmacovigilance systems
  • To act as Livingston site representative for Product Safety Review Board. Escalation of relevant issues to and from committee meetings/Global Quality Focus Groups
  • To assist with the preparation, review and approval of technical / quality agreements for suppliers and service providers
  • To prepare and/or review and approve Quality Investigations which impact on cGMP related activities and batch disposition decisions
  • In compliance with UK, EU/FDA quality rules and guidelines, to manage the resources, procedures and reports necessary to ensure effective execution of the external supplier audit program to a defined schedule, in conjunction with Global Quality Assurance
  • In conjunction with QA, to perform external audits and internal audits as deemed necessary (e.g. for-cause investigations and unscheduled cGMP audits). Provide support to management during third-party audits
  • To independently verify the audit reports and programme compliance, escalate any adverse trends or major non-conformances reported and make recommendations on appropriate corrective action in support of the approval / rejection of suppliers or products
  • To identify areas of improvement for internal and Global Quality Systems/procedures and to provide support with the implementation of such improvements
  • In conjunction with the concerned departmental personnel, develop suitable reporting mechanisms (e.g., key quality indicators) which provide assurance of effective quality oversight of both internal and externally contracted manufacturing and testing activities
  • To keep up to date with current guidelines and regulatory requirements (e.g. Pharmacopoeial changes) in respect of quality requirements
  • Implement and maintain Standard Operating Procedures, as required
  • To undertake any other duties as requested by the line manager in accordance with company requirements

Education/Experience

  • Degree level education or equivalent experience
  • Eligible QP (UK qualified, under the Permanent Provisions)
  • Relevant experience of UK, EU and FDA cGMP requirements for the manufacturing and testing of biopharmaceutical products in a commercial environment
  • Good understanding and working knowledge of the Pharmaceutical Industry

Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

As part of the ongoing expansion project in Livingston we are now seeking interest for key roles within the Manufacturing team, including Manufacturing Supervisors.

Job Summary

To co-ordinate the execution of manufacturing steps according to defined procedures and protocols, in line with cGMP work practices and quality standards. This role is dedicated to the supervision of production, production resources and will review, organise and where necessary develop systems / processes in order to achieve:

  • Effective supervisory control production activities within functional area
  • Effective management of a team of manufacturing scientists/operatives
  • Effective planning and co-ordination of activities within functional area
  • Liaise with support functions to ensure appropriate use of resource

Responsibilities

  • On a day to day basis, co-ordinate manufacturing technicians to execute production activities to deliver product on time, right first time and within budget
  • Ensure that all production steps defined by SOPs, production records and protocols are executed in compliance with cGMP standards
  • Ensure that shift handovers are carried out effectively
  • Ensure that direct reports are appropriately trained and competent in procedures
  • Ensure procedures reflect expected manufacturing techniques and current best practice
  • Effective management of people including; holidays, overtime, absence, performance, disciplinary and grievance
  • Development of manufacturing scientists/operatives within team
  • Effective root cause analysis of events and implementation of appropriate corrective actions
  • Ensure the manufacturing areas are audit ready at all times
  • Ensure compliance with health and safety requirements including reporting and investigating incidents
  • Undertake any other duties as requested by line manager in accordance with company requirements

Job Requirements

Experience:

  • Educated to degree level in relevant qualification, or equivalent experience
  • Minimum of 3 years relevant production experience
  • Experience in manufacture of pharmaceutical, vaccine and/or medical devices
  • Experience of managing people is highly desirable
  • Experience in lean manufacturing/six sigma is highly desirable

Required Skills:

  • Strong communication and leadership skills
  • Technical understanding of biotechnology manufacturing processes
  • Leads by example and acts with integrity
  • Ability to work under pressure and effectively manage priorities

Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

To help support growth and development of our Vaccines we are actively looking for a Vaccine or Biologics Health Science focussed Deputy Head our of Process development Team. You will undertake the management of a highly experienced team of development scientists in the delivery of new vaccine products from early development into manufacturing. Technology Transfer, scale up, optimisation, implementation and GXP manufacture using technical and scientific expertise in the Vaccine / Biologics discipline. Further scale up / optimisation for robustness, consistency and yield for commercialisation. Provide site wide technical and investigational support through data evaluation and laboratory work. This is a high profile role with Global Valneva responsibilities and interactions at senior levels of the site and company.

Responsibilities

  • Manage and lead new vaccine product introduction by Technology Transfer. Ensure effective and timely new process establishment with a hands on approach
  • Lead multi-disciplinary project teams to ensure on-time initiation of clinical manufacture for new or upscaled vaccine products
  • Manage the GXP manufacture, closure and reporting of clinical vaccines, including cell banks, viral banks and vaccine batches through to sterile bulk Drug Product formulation
  • Identify and manage delivery of process development / improvement projects, from conception to validation, with a view to increased process robustness, yield and success rate or reduced COGs
  • Management of experienced senior scientists to ensure ownership and delivery of assigned project tasks, systems and areas of responsibility to agreed target dates
  • Provide technical expertise, troubleshooting and lead key technical investigations / assessments, utilising critical trended data to support on time delivery of Quality Investigations
  • Support regulatory submissions by provision or review of technical reports and/or data
  • Ensure development Proposals, Plans and Reports are generated with appropriate risk & commercial considerations, impacts and milestones for delivery, and aligned with business requirements and site projects, goals & objectives
  • To deputise for the Head of Function or other departmental colleagues as required
  • Deliver key critical data for the identification and mitigation of process risks or failure mechanisms through trending and escalation
  • Drive continuous process improvement and provide technical support to key site projects and business deliverables
  • Manage and track on time delivery of department owned Quality Management System actions and documentation
  • Represent the company to external contacts such as customers, suppliers and regulatory authorities for technical discussions
  • Lead by example in the development and maintenance of an enthusiastic, supportive and collaborative environment within the team, across the site and between sites
  • Shift work and out of hours work as required
  • To undertake any other duties as requested by the line manager in accordance with company requirements

Job Requirements

Experience:

  • PhD qualified preferable, or extensive additional relevant experience in Vaccines / Biotech discipline
  • Extensive experience (10+ years) of working within the Vaccine or Biologics Health Science Industrial sector, in Process / Assay Development, Manufacture or Analytical functions, particularly viral products
  • Proven track record in leadership of major, complex, time critical, multi-disciplinary projects involving diverse departmental teams
  • Proven Line Management capabilities of experienced Senior Scientists (5+ years)
  • Excellent understanding of protein chemistry and characterisation and their application to clinical manufacture processes
  • Strong GxP understanding and experience
  • Strong commercial awareness and demonstrable leadership
  • Good experience of statistical data analysis and process trending
  • Good experience of change management and risk analysis

Required Skills:

  • Excellent Scientific understanding of vaccines or protein chemistry through development, manufacture or analytics
  • Ability to confidently communicate at all levels of organisational structure
  • Excellent team management
  • Strong strategic prioritisation capability
  • Analytical thinking
  • Team player with awareness of impact on people, process and systems

Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical needValneva has leveraged its expertise and capabilities both to successfully commercialise two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19. 

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

An opportunity has arisen at Valneva Scotland for a Principal QA Specialist within the Quality Assurance Department to support our team in Livingston.

Job Summary

To provide quality technical expertise for the development, optimisation and introduction of quality management processes associated to manufacturing site operations for existing and proposed new products.  To define, develop and deliver implementation of improvement quality projects for robustness, consistency, success and enhanced outputs.

Responsibilities

  • Act as main support to quality assurance management team including the Head of Quality Assurance and Head of Quality Operations assuming responsibility for reporting status position, providing updates on departmental activities and risks
  • Deputise for the line manager (Head of Quality Assurance) and team colleagues as required, and ensure owned tasks are assigned deputies in their absence
  • Provide and support the leadership of the quality management team during third-party audits
  • Monitor, improve and maintain quality management procedures to ensure compliance with EU / FDA Good Manufacturing / Distribution Practice as well as other appropriate regulatory authorities for the manufacture and testing of pharmaceuticals
  • Lead, co-ordinate and support all quality management systems in accordance with relevant Standard Operating Procedures, including but not limited to:
    • CAPA
    • Change requests
    • Deviations (including Quality Investigations and OOS)
    • Complaints (customer / supplier)
    • Development Studies / Reports
    • Risk Management
    • QMS data logs
    • Room Release documentation
    • Batch record review (including PPRs, PTRs, MPRs, SPRs)
    • Supplier Assurance processes (including external audits)
    • Validation
  • Progress department QMS activities to agreed timelines
  • Be accountable for on time document management and performance measurement
  • Lead and support the delivery of key quality metrics for the Quality Management Systems ensuring such metrics are available to management to drive continuous improvement and compliance with current regulations, quality requirements and Valneva business needs. Presentation of key Quality Metrics to the Site monthly QRB
  • Lead and assume responsibility for trending and reporting on batch review/release process and quality management system data
  • Utilise critical quality management trended data to support site management of changes. Additionally analyse key critical quality data for the identification and mitigation of process risks or failure mechanisms through trending and escalation
  • Act as main site wide quality expert including being key role in troubleshooting and lead key technical investigations, risk assessment, change management and site projects
  • Provide principal quality assurance support and leadership in the implement of site project activities which will support the commercial manufacturing process
  • Identify and lead the delivery of quality improvement projects, from conception to implementation, with a view to increased quality robustness and oversight to support site commercial manufacturing activities
  • Perform training of staff within the quality assurance department, across the site and between sites in areas of expertise where required
  • Actively contribute to the development, maintenance, support and collaborative of an effective working environment within the quality assurance team, across the site and between sites
  • To deputise where appropriate and undertake any other reasonable duties as requested by the Head of Quality Assurance, in accordance with company requirements
  • Shift work and out of hours work as required

Experience

  • Experience of working within a GMP / GDP manufacturing environment
  • Experience of working within MHRA / EU / FDA accredited facilities
  • Previous experience of working to tight deadlines and re-prioritising workload
  • Proven experience of working with operational excellence improvement tools
  • Experience of leading and delivering quality metrics

Required Skills

  • Strong attention to detail
  • Clear and effective communication skills
  • A logical approach to problem solving
  • Pro-active self-starter with ability to engage and motivate others
  • Proven ability to manage own workload
  • Ability to analyse and interpret quality data
  • Multi-tasker with ability to work to changing priorities
  • Ability to work to own initiative and successfully contribute as part of a team

Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical needValneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19. 

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

An opportunity has arisen for a QC Lab Manager (Micro) to join our team in Livingston based team on a 12 month fixed term contract.

Job Summary

To provide oversight and co-ordinate the routine running of the QC Microbiology. Provide technical expertise and guidance to support Sterility Assurance, Microbiology and Facility Contamination Control (FCC) initiatives on site.

Responsibilities

  • Ensure that EOHS requirements are met by the team, including individual/team training, and that any incidents are investigated and reported in a timely manner to the Head of Quality Control and the EOHS department.
  • To manage Microbiology activities in support of manufacturing schedules and support FCC activities
  • Oversee the execution of microbiology activities according to defined SOPs and protocols with timely reporting of issues to relevant staff
  • Provide support as Subject Matter Expert (SME) in microbiologically related investigations and other problem solving forums
  • Maintain knowledge and competence to undertake tasks within the team, for example, at times of absence or high workload
  • Ensure testing in the microbiology laboratories is scheduled and performed in a timely manner and in alignment with the Manufacturing Master Planning Schedule
  • Manage and maintain facilities, resources and equipment required to adequately support microbiology activities
  • Ensure direct reports are appropriately trained and competent in the procedures they are conducting, and are in compliance with cGMP working practices at all times
  • Immediately escalate and report any deviations to materials, facilities, processes or procedures to the Head of Quality Control, Head of Facility Contamination Control (FCC) and Qualified Person (QP)
  • Manage and co-ordinate on time delivery of QMS documentation by the team
  • Ensure the principles of Data Integrity are deployed within the team and that issues are escalated to the Head of Quality Control in a timely manner
  • Ensure high standards of housekeeping are maintained within areas of responsibility
  • Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative team within QC
  • Develop, collate and report key quality/business related metrics, and use such metrics to drive a culture of continuous improvement and process efficiencies within areas of responsibility
  • Contribute, encourage and support staff development activities
  • To undertake any other duties as requested by the line manager in accordance with company requirements
  • Support shift and out of normal hours work, including weekends, as required to support business requirements
  • Deputise for the Head of QC during times of absence or a need for technical expertise

Experience

  • Educated to degree level or equivalent experience
  • Experience within a QC Laboratory working to GMP within a recognised quality system (3+ years)
  • Knowledge of GMP guidelines and regulatory bodies
  • Previous supervisory experience in a lab environment preferred

Required Skills

  • Ability to lead and co-ordinate work within a busy QC laboratory
  • Ability to motivate and engage an effective workforce
  • Ability to develop and manage change projects effectively and efficiently
  • Effective communication and presentation skills (for internal and external interactions)

Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical needValneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19. 

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

As part of the ongoing  project in Livingston we are now seeking interest for key  roles within the Manufacturing team and are seeking interest in our Manufacturing Shift Leader positions.

Job Summary

To co-ordinate the execution of manufacturing steps according to defined procedures and protocols in line with cGMP work practices and quality standards.  This role is dedicated to the management of production, production resources within a shift and will review, organise and where necessary develop systems / processes in order to achieve:

  • Effective control of all production activities
  • Effective management of a small team of supervisors
  • Effective planning and co-ordination of activities within manufacturing
  • Effective planning and co-ordination with support functions

Responsibilities

  • On a day to day basis coordinating all supervisors and senior technicians to co-ordinate production plans within a shift in order to deliver product to appropriate time, quality and costs
  • To make sure that all production steps defined by SOPs, production records and protocols are being executed in compliance with cGMP standards
  • Ensuring manufacturing rooms are prepared ready for activities, pick lists submitted in time to ensure raw materials available.  PPRs and labels available in room prior to activities commencing
  • Ensure that there are clear systems for shift handovers
  • Working in cleanrooms / supervising activities as required
  • Ensuring that all paperwork has been completed for room activities prior to staff leaving room
  • To oversee that best cGMP work practices and techniques to produce product within specification are being applied, ensuring that when in operation equipment, facilities and materials used in the area of responsibility comply with defined standards
  • Ensure that all production supervisors and staff are appropriately trained and competent in the procedures they are conducting and are in compliance with best cGMP working practices at all times
  • Ensure PPRs are kept up to date to reflect expected manufacturing techniques to remove any ambiguity in instructions
  • Responsibility for coordination and planning of cellbank activities
  • Responsibility for coordination and planning FBS qualification activities
  • Responsibility for coordination and planning virus seedbank manufacture
  • Responsibility to motivate supervisors and their staff to help when there are additional pressures
  • Promptly reporting any issues requiring engineering intervention
  • Develop and ensure delivery of a training plan to build on the skills of current production personnel and allow rapid contribution from new personnel
  • Be responsible for the development, collating and reporting of key quality and business metrics and use such metrics to drive a culture of continuous improvement
  • Identifying opportunities for improvements
  • Responsibility for ensuring that any deviations, change controls or CAPAs related to materials, facilities, processes or procedures within your shift are escalated and addressed within agreed timelines.  Reviewing and approving QMS items, ensuring that they are completed to a high standard
  • Liaise with all manufacturing staff, ensuring that all direct and indirect production areas are clean, tidy and well organised and in a state of continuous inspection readiness
  • Conduct all activities in the most careful and safe manner and in full compliance with HSE requirements
  • Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team setting
  • Completion of Goals and Objectives, 121s, mid year reviews and end of year reviews for staff, within expected timelines
  • To undertake any other duties as requested by line manager in accordance with company requirements

Job Requirements

Experience:

  • Educated to degree level in relevant qualification, or equivalent experience
  • Minimum of 5 years relevant production experience at senior level
  • Proven track record of supervising a team of 4 or more
  • Experience in vaccine production / commercial
  • Animal cell culture experience
  • Cell bank experience

Required Skills:

  • Flexibility, as there may be a variance in daily schedules from time to time (shift / weekend)
  • Good understanding and working knowledge of the Pharma industry
  • Maintenance of a professional attitude
  • Confidence in dealing with difficult staff
  • Encouraging and developing staff
  • Ability to recognise staff behaviours, rewarding good behaviours and swiftly dealing with any issues
  • Ability to develop a team culture