Valneva is a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need. The Company has several vaccines in development, including unique vaccines against Lyme disease, COVID-19 and chikungunya. Valneva’s portfolio also includes two commercial vaccines for travellers.

A fantastic new opportunity has arisen to join our Finance Team as we experience an exciting time of growth, suited to a NQ level Accountant who is ready to embark on a career within Industry.

This role will support the local finance director and existing local finance controller during a period of substantial growth for the business by having responsibility for day to day management of a number of key financial systems and processes ensuring adherence to external and internal regulations.  The role will also support the business growth through ad hoc project work from time to time.

RESPONSIBILITIES

  • Responsibility for a number of month end close balance sheet and profit and loss account processes
  • Maintenance and control of the purchase and sales ledger which may include supporting the AP clerk with processing of documentation during growth phase
  • Responsibility for the timely payment of all suppliers in accordance with Valneva Scotland Ltd terms of business
  • Deal with any escalated supplier queries and resolve promptly
  • Management of COGS and Inventory cycle
  • Fixed asset register management
  • Maintain and reconcile cash
  • Ensure accuracy and maintenance of Accruals, Intercompany and Prepayments
  • Out of hours work as required by the business from time to time to support the accounting calendar
  • Assist with completion of budget and forecast cycles where requested
  • Assist with preparation and analysis of draft management accounts and commentary
  • Assist with preparation and information gathering for ad hoc financial modelling
  • Assist with completion of HMRC documentation in relation to VAT including submission of return
  • To undertake any other duties as requested by the line manager in accordance with company requirements

JOB REQUIREMENTS

Experience

Essential

  • Either holder of a recognised Accounting Qualification, nearly qualified or be qualified by experience

Desirable

  • Have knowledge and experience of working in or alongside small and medium enterprises
  • Have knowledge and experience of working in the pharmaceutical or healthcare industries
  • Have knowledge and experience of standard costing
  • Have knowledge and experience of internal controls and SOX
  • Have experience of working with colleagues internationally

Required Skills

  • Intellectually curious, with a desire to learn about their chosen industry / sector
  • High level of consistency, accuracy and numeracy
  • Proactive and positive mind set, which embraces change
  • Excellent Microsoft Office skills
  • Knowledge of ERP accounting and Microsoft AX
  • Ability to be flexible and collaborate to support the success of a small team

Valneva is a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need. The Company has several vaccines in development, including unique vaccines against Lyme disease, COVID-19 and chikungunya. Valneva’s portfolio also includes two commercial vaccines for travelers. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with approximately 580 employees.

Due to the increase in business, we are now looking to recruit QC Technicians (Analytical) to join our team in Livingston.

Experience

  • Working within a QC laboratory to cGMP
  • Aseptic technique
  • Writing and working to SOP documentation
  • Analytical methods experience in a production-focused environment including Haemagglutination assay, ELISA, dye binding colorimetric assays (Bradford Method, Coomassie Plus), Electrophoresis, Cell Culture, Plaque assay, Western Blot.
  • Assay development, validation and transfer experience
  • Experience of working within Quality Management Systems which include deviations, change controls and CAPA’s

Responsibilities

  • Execute analytical procedures, for testing of raw materials, intermediate products and final products, according to defined SOPs and protocols
  • Ensure that all necessary training is complete in the procedures conducted, and operate in compliance with cGMP working practices at all times
  • Conduct on-time reporting according to the defined and trained document management standards including review and verification of analytical data
  • Ensure the laboratories are in a constant state of inspection readiness
  • Ensure that at any time equipment, facilities and materials used in the QC laboratories comply with defined standards
  • Support change controls, investigations and CAPA’s
  • Identify areas for continuous improvement and escalate those to Line Manager
  • Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team setting
  • Storage of in process, and final products samples including, for stability and retention purposes
  • Preparation of SOPs (where applicable) in accordance with Valneva Quality systems
  • Perform filing duties and other QC administrative duties as required by the line manager
  • To undertake any other duties as requested by the line manager in accordance with company requirements
  • Shift work and out of hours work as required

Valneva is a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need. The Company has several vaccines in development, including unique vaccines against Lyme disease, COVID-19 and chikungunya. Valneva’s portfolio also includes two commercial vaccines for travelers. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with approximately 580 employees.

Due to the increase in business we are currently recruiting Facility Engineers in Scotland.

Job Summary

To supervise and 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

You Will Have:

  • Engineering degree 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 and calibration programs
  • 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

Additional Required Skills:

  • Good communication and skills
  • Ability to work on own initiative and as part of a team

Valneva is a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need. The Company has several vaccines in development, including unique vaccines against Lyme disease, COVID-19 and chikungunya. Valneva’s portfolio also includes two commercial vaccines for travelers. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with approximately 580 employees.

Due to the increase in business we are currently recruiting for a Stores Person to work at our Livingston site.

Job Summary

To support all Supply Chain activities including receipt of all raw materials and consumables, stock control and transferring materials between Valneva sites. Adhering to Valneva policies, ensure raw material stocks are available in the right locations at all times.

Responsibilities

  • Receipt and quarantine of supplies
  • Identify and take responsibility for achieving personal training standards required
  • Take personal responsibility for the safe operation within the Warehousing
  • Awareness of the relevant modules of Valneva’s electronic supply management system
  • Support in the implementing of systems, policies and procedures for effective running of the stores, taking into account any relevant regulatory requirements.
  • Receiving deliveries and ensuring that the material conforms to that specified on the purchase order and internal specifications
  • Inform QC of materials that require release approval and move all deliveries to the appropriate areas
  • Operate first in first out (FIFO) policy and first expired (FEFO) for raw materials and consumables
  • Replenish the stock via the inventory management process, ensuring stock is available on time
  • Clear stores of any un-used and expired material as per standard operating procedures
  • Maintain high standards of housekeeping in the warehousing areas
  • You will be required to travel between Valneva Scotland sites
  • You will be required to drive company vehicles including transferring materials between sites
  • You will be required to work different shift patterns between Day shift/Back shift and continental shifts as determined by the business needs.
  • Removal of the waste generated by Goods In
  • To undertake any other duties as requested by the line manager in accordance with company requirements
  • You will also be responsible for your own QMS

Job Requirements

  • Stores experience preferably within a structured (GMP/GLP) environment
  • Current driving licence pre January 1997 to allow driving of company vehicle
  • Forklift, Counter Balance and Reach Truck Experienced preferred

Required Skills

  • Strong attention to detail
  • Good communication skills

Valneva is a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need. The Company has several vaccines in development, including unique vaccines against Lyme disease, COVID-19 and chikungunya. Valneva’s portfolio also includes two commercial vaccines for travelers. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with approximately 580 employees.

A vacancy has arisen within Valneva Scotland’s Quality Control Department for a QC Co-ordinator (Logistics).

Job Summary 

We are looking for a positive and enthusiastic individual with a continuous improvement mind set to join and contribute to the QC team whilst maintaining compliance with our Quality Management System.

Out of hours working and/or overtime may be required due to business needs.

Key Responsibilities­

  • Organise testing and shipment of QC samples and materials to approved test houses, including Valneva Austria, using defined procedures
  • Align sample shipments and return of expected results to the manufacturing schedule whilst maintaining GMP compliance
  • Act as the Subject Master Expert (SME) for QC sample planning to coach/train others, as appropriate, to undertake the role at times of absence
  • Act as central point of contact for QC for the receipt of CofAs from Valneva Austria and approved test houses
  • Raise purchase requisitions for in process, final product, and raw material testing as required.
  • Co-ordinate the storage of QC samples including maintenance of inventory logs, execution of routine stock checks and discard of applicable materials
  • Co-ordinate the sampling of materials to support shipment schedules and analysis
  • Apply best GMP work-practices and techniques to sampling
  • Co-ordinate the release of raw materials ensuring the availability of materials to support the manufacturing, supply chain, and QC testing schedules
  • Write, manage and progress QMS documentation to meet agreed target dates
  • Immediately escalate and report deviations and issues through line management that may potentially impact sample shipment and/or analysis of materials required for the manufacturing schedule and QC testing schedules
  • Ensure allocated area(s) adhere to 5S working practices and high levels of cleanliness are maintained to ensure a state of inspection readiness
  • Identify continuous improvement opportunities and liaise with QC line management (or other functions) to agree benefits and deployment plans
  • Perform routine housekeeping activities in QC including cleaning of equipment and laboratory areas
  • Ensure that all required training is complete in procedures performed and operate in compliance with best GMP working practices at all times
  • Actively contribute to the development of the QC Logistics team, for example, through team meetings

Other Responsibilities

  • Deputise for the QC Raw Materials Co-ordinator and support the release of raw materials
  • Act as departmental point of contact on relevant site projects
  • Support other QC activities in line with the manufacturing schedule

Experience

  • Degree in biological sciences or relevant experience
  • Knowledge of GMP guidelines and regulatory bodies Biologics / vaccine background preferred
  • Experience of Quality Management Systems
  • Experience in working with Microsoft Excel, and ERP systems
  • Experience of working to deadlines and managing conflicting priorities
  • Experience working effectively in a team, influencing as appropriate

Competencies

  • Attention to detail
  • Excellent organisational skills
  • Effective communication skills
  • Flexible and adaptable team player
  • Ability to think analytically

Valneva is a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need. The Company has several vaccines in development, including unique vaccines against Lyme disease, COVID-19 and chikungunya. Valneva’s portfolio also includes two commercial vaccines for travelers. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with approximately 580 employees.

An opportunity has arisen at Valneva Scotland for a QC Technician – Micro.

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 equipment, facilities and materials used in the QC laboratories comply with defined standards
  • Adhere to 5S working practices. Identify and implement areas for continuous improvement and escalate to Lab 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 all required training is complete in procedures performed and operate in compliance with regulatory requirements
  • 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

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
  • Experience in cell culture and virology assays desirable
  • Biologics / vaccine background ideal
  • Experience managing external relationships for effective delivery, e.g. vendors, test houses
  • Experience of Quality Management Systems
  • Experience of working to deadlines and managing conflicting priorities

Required 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

Due to the increase in business we are currently recruiting for Engineer Technician to work at our Livingston site.

Job Summary

To execute defined procedures for calibration, qualification and maintenance of equipment / facilities, in compliance with applicable cGMP standards, regulations, techniques, best practice and business metrics.

Responsibilities

  • Perform routine calibrations and qualifications of various equipment ensuring compliance defined by SOPs, protocols and procedures
  • Apply cGMP / GEP work practices and techniques in compliance with regulatory requirements
  • Observe and assist in plant and facilities maintenance
  • 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
  • To undertake any other duties as requested by the line manager in accordance with company requirements
  • Shift work and out of hours work as required
  • On Call rota

Job Requirements

  • ONC/HNC in an engineering discipline
  • Relevant work experience in a GMP environment preferred
  • Ability to work in a cleanroom environment
  • Good report writing skills

Required Skills

  • Good communication skills
  • Ability to work on own initiative and as part of a team
  • Reliable and enthusiastic

Do you have a background in Quality Assurance Document Management ? If so, we’d love to hear from you! Valneva is an award-winning, speciality vaccine company providing prevention against diseases with major unmet medical needs, and we are currently hiring for a QA Specialists within Document Management to join us during this unprecedented time of growth.

Job Summary

Responsible for document control and document archive.  Assist in maintaining a comprehensive quality management system to achieve inspection readiness all portfolio products

Responsibilities

  • Maintain a system of document control to meet the requirements of the company, taking into account any regulatory requirements i.e. GDP I cGMP I FDA
  • Maintain company archive and pre archive system to ensure adequate and secure protection of quality documentation and data.
  • Manage databases within the Quality System
  • Good Manufacturing Practice for the manufacture and testing of pharmaceuticals
  • Provide support during audits of Valneva Scotland Ltd
  • Support and take part in Continuous Improvement activities
  • Provide support for Pilgrim electronic document management system where required
  • Perform training in areas of expertise where required
  • Work within the Global Quality team to ensure efficient and effective roll-out of Global Quality Documents
  • Support Quality Assurance activities as directed by line manager or Head of Quality Assurance
  • Provide administrative support for Quality Assurance activities as directed by line manager or Head of Quality Assurance
  • To undertake any other duties as requested by the line manager in accordance with company requirements

Job Requirements

Experience:

  • Relevant experience in business administration/ document control and archiving
  • Experience of GMP environment and specifically Quality Operations/ Quality Assurance

Required Skills:

  • Self-motivated and conscientious team player
  • Effective communication skills
  • Excellent organisational skills

Do you have a background in Validation ? If so, we’d love to hear from you! Valneva is an award-winning, specialty vaccine company providing prevention against diseases with major unmet medical needs, and we are currently hiring for a Senior Validation Specialist to join us during this unprecedented time of growth.

Job Summary

To assist with the definition and implementation of operational validation activities that ensure effective oversight of and verification that validation activities are in compliance with EU/FDA regulatory requirements.

Primary functions of the job are to:

Support, lead and advise on process validation, assay validation, software validation, shipping validation and equipment qualification in line with training and experience.

Act as subject matter expert in regulatory inspections of these areas as appropriate.

Responsibilities

  • Reporting to the Head of Validation, assist in the development, definition and implementation of operational validation activities.
  • To identify areas of improvement for validation systems/procedures and to provide support with the implementation of such improvements.
  • Generate and/or perform reviews of validation documentation in accordance with relevant Standard Operating Procedures, including but not limited to:
    • Validation Master Plan(s)/Validation Plans
    • Validation Protocols
    • Validation Reports
  • Participate in project groups, set acceptance criteria and define the data requirements necessary to ensure that validation work is compliant. To ensure that the Head of Validation and other key stakeholders are informed of validation matters which may have an adverse impact on the validation status of facilities, equipment systems, the manufacturing process on product disposition (e.g. batch/lot release decisions).
  • Investigate and report Quality Issues, escalating to management as required.
  • To compile key quality data for the validation program and to make such data available to management to drive a culture of continuous improvement that is fully compliant with current EU/FDA regulations and quality requirements and Valneva Scotland Ltd business needs
  • To keep up to date with current guidelines and regulatory requirements in respect of internal and external quality requirements.
  • To provide and/or coordinate training in validation related procedures/concepts as appropriate to meet business needs.
  • Provide support during internal/external and third-party audits.
  • Any other reasonable duties as requested by the Head of Validation.

Job Requirements

Experience

  • HND level or equivalent experience
  • Working knowledge of validation within a GMP manufacturing environment
  • Working knowledge of process validation in a biopharmaceutical or pharmaceutical manufacturing environment
  • Robust working knowledge of at least two of the following:
    • Validation of aseptic processes (including filling),
    • Validation of Computerised systems,
    • Equipment Qualification,
    • Process Validation,
    • Assay Validation,
      • Cleaning Validation.

Experience as a validation subject matter expert (in the above topics) in regulatory inspections.

Required Skills

  • Effective communication skills across all personnel levels and function areas
  • Good working knowledge of Microsoft Office including Word, Excel, PowerPoint and Project
  • A logical approach to problem solving
  • Good organisational abilities
  • Ability to operate with minimal direct supervision
  • Ability to train staff across all personnel levels and functional areas

Our Program Manager is first point of contact for UK government managing information flow within the Valneva Program.

Acting also as the COVID Program Management Officer, who  plans, monitors and manages the COVID Program across all its constituent projects. Leads or coordinates project planning, resourcing, staffing, progress reporting, and troubleshooting. Ensures project results meet requirements regarding schedule and cost. Monitoring performance and recommends schedule changes, cost adjustments or resource additions.

Supports alignment between manufacturing sites and drives teams to jointly meet timelines.

Responsibilities

  • Responsible for management of external stakeholder
  • Act as local relationship owner for key stakeholders with UK Government
  • Work with the Program Director and other senior staff to prepare content ahead of key governance meetings and ad-hoc meetings as required
  • Responsible for setting-up, monitoring and management of assigned program / project timelines and activities from initiation through completion conduct with a primary focus on milestone achievements.
  • Support each department with their Covid strategy and tracking (e.g. HR, Finance)
  • Uses formal processes and tools to manage progress, resources, budget, risks meetings and changes
  • Aligns CMC teams across all sites to ensure achieving necessary milestones/ timelines
  • Generate transparency of the projects ensuring routine reporting to the respective committees. Internal communication within the COVID Program
  • Promote and foster a strong team culture and open and transparent communication
  • Lead and moderate together with Program Director virtual program and project teams across sites. Deputise for Program Director where appropriate and required
  • Support Valneva’s management board and program directors on other strategic activities, as required

Job Requirements

Education / Experience:

  • Scientific or engineering background
  • Relevant experience in project management, management consulting, corporate development, or another related field (7+ years); PM certification / qualification is appreciated
  • Experience in biotech and pharmaceutical production environment

Required Skills:

  • Strong interpersonal and leadership skills to influence and build credibility with internal & external Stakeholders
  • Excellent analytical and problem solving skills; ability to see the “big picture”
  • Understand key dynamics of a business/industry while maintaining good attention to detail
  • Strong experience within strategic projects and topics
  • Successful project management experience in facilitating cross-functional, complex projects in a fast-paced environment and managing multiple project deadlines and priorities
  • Ability to structure and manage complex cross-enterprise projects and processes with multiple stakeholders at both senior and junior levels
  • Produces high quality reporting and analysis to management as well as ad hoc analyses and reports, as directed.