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.  Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the US with over 500 employees.

An opportunity has arisen at Valneva Scotland for an HR Manager.

Job Summary

Lead and manage HR team to ensure all HR systems and processes for the Company are being developed and executed in a compliant manner.  Provide full strategic HR support to the site executive team, ensuring an approachable and professional HR service to all, which offers effective solutions for business needs. Advising and coaching Line Managers, Function Heads and other customers in the efficient and consistent application of HR policies and procedures which reflect business needs and current legislation including advising of any updates. Maintaining a mind-set, which promotes positive values and behaviours in all interactions throughout the site.

Responsibilities

  • Represent and facilitate a professional, knowledgeable and current HR service to the site, encouraging the team contribution to ensure consistent service levels
  • Lead all recruitment, deployment and HR contractual change processes
  • Be responsible for the development, collating and reporting of key quality and business metrics related to HR and use such metrics to drive a culture of continuous process improvement.
  • Manage and oversee the effective and qualitative data from HRM system
  • Implementation of HR aspects of any major change program in accordance with agreed timescales, deliverables etc. established for the program in question
  • Actively contribute to the development of an enthusiastic, supportive and collaborative environment across the site
  • Advice to senior managers on appointments, remuneration, development, performance management, etc.
  • Provide general day to day HR support on operational issues, with best-fits needs approach for the business
  • Management of maternity / paternity and flexible working arrangements in line with legislation and company policy
  • Developing and maintaining effective ER relationships with all staff
  • Continually seek to challenge and make recommendations to the HR Director on new HR initiatives which are cost effective and support business activities
  • Responsible for managing the annual performance management process including sign off for all G&Os across the site
  • Attend and contribute to corporate HR workshops involved in the integration, harmonisation and implementation of new or updated policies and processes for business needs
  • Immediately escalate any material breach to employment law or internal HR policies to MD
  • To undertake any other duties as requested by the HR Director and HSE in accordance with company requirements

Experience

  • Educated to degree level / equivalent experience in HR
  • Good understanding of business and strategy development processes
  • Successful track record of relationship management
  • Well rounded HR professional
  • Working with senior teams on complex change
  • Experience of working in and providing support in a busy, fast-paced environment
  • Experience of coaching and advising line managers in all aspects of employee relations

Required Skills

  • Excellent communication skills
  • Sound grounding in the broad HR skillset and up to date knowledge of HR developments
  • Focus and flexibility; comfortable with change and ability to adapt advice to each individual situation
  • Emotional resilience; ability to challenge and provide guidance / advice at an appropriate level taking into account different perspectives
  • Strong organisational and interpersonal skills, particularly strong attention to detail
  • Up to date and strong knowledge of Employment Law
  • Effective team member in a multi-disciplined team
  • Strong negotiator with ability to see multiple viewpoints and apply advice in right way
  • Functional expert with drive to be a commercial influence for the success of the business

Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. We have leveraged our 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.

Due to the increase in business, we are now looking to recruit QC Scientists to join our team in Livingston.

Experience 

  • Educated to degree level
  • 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 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 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 600 employees.

A vacancy has arisen within Valneva Scotland’s Quality Control Department for a QC Co-ordinator (Logistics) for 12 month FTC

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

Valneva is a specialty vaccine company focused on prevention against diseases with major unmet needs. Valneva’s portfolio includes two commercial vaccines for travelers and various vaccines in development including unique vaccines against Lyme disease, chikungunya and COVID-19.

Valneva have a number of opportunities for Individuals with previous validation experience for our newly built manufacturing premises in Livingston.

Job Summary 

We are actively recruiting for Validation Specialists to assist with the definition and performance of operational validation activities that ensure that validation activities are in compliance with EU/FDA regulatory requirements and applicable guidelines.

Perform, witness and provide support and advice for required validations and qualifications on site. Acting as subject matter expert in regulatory inspections as appropriate based on involvement within the validation or project activities.

You will be responsible for:

  • Reporting to the Head of Validation, assist in the operational validation activities, including physically performing Equipment and Facility Qualifications.
  • Identify areas of improvement for validation systems/procedures and to provide support with the implementation of such improvements.
  • Generate and complete validation documentation in accordance with relevant Standard Operating Procedures, including but not limited to:
  • Validation Plans
  • Validation Protocols
  • Validation Reports
  • Participate in project groups and 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 Scotland.

Education / Experience:

  • HND level or equivalent qualification in relevant subject (required).
  • Working knowledge of Equipment Qualification and/ or Facility Qualification in a biopharmaceutical or pharmaceutical GMP environment (required).
  • Working knowledge of validation principles in at least one of the following (preferred):
  • Validation of aseptic processes (including filling),
  • Validation of Computerised systems,
  • Process Validation,
  • Assay Validation,
  • Cleaning Validation.
  • Experience in regulatory inspections (preferred).

You will have:

  •  Effective communication skills across all personnel levels within the organisation and with contractors / external engineers.
  • Good Writing skills for completion of documentation and report writing.
  • Good working knowledge of Microsoft Office including Word, Excel and PowerPoint.
  • A logical approach to problem solving
  • Good organisational and effective prioritisation skills
  • Ability to operate with minimal direct supervision

An opportunity has arisen in Livingston for Manufacturing Process Technicians.

JOB SUMMARY

The purpose of this role is to execute defined and trained manufacturing steps for the large-scale production of a Covid-19 vaccine candidate, according to set procedures and protocols whilst adhering to best cGMP work practices and Quality standards.

KEY RESPONSIBILITIES

  • Execute production steps defined by SOPs, production records and protocols for manufacture of our Covid-19 vaccine candidate
  • Setting up, operating and monitoring complex manufacturing equipment
  • Apply best cGMP work practices and techniques
  • Conduct on-time reporting according to defined document management standards
  • Immediately escalate and report any deviations to materials, facilities, processes or procedures to the supervising team
  • Conduct all activities in the most careful and safe manner and in full compliance with HSE requirements
  • Ensure that at any time, equipment, facilities and materials used in the area of responsibility comply with defined standards
  • Support change controls & investigations in the most diligent manner
  • Identify areas for continuous improvement and escalate those to the respective manufacturing supervisor or appropriate line manager
  • Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team setting
  • Choose & commit to work one of the various shift patterns on offer
  • To undertake any other duties as requested by the line manager in accordance with company requirements
  • Be accountable that the individual workspace is clean, tidy and well organised

EXPERIENCE

  • Relevant degree, HNC/HND or equivalent experience
  • Experience as a key operator on setting up and operating complex manufacturing equipment
  • Cleanroom experience
  • Experience of working within a cGMP environment
  • Experience of following SOPs within defined cGMP work practices

COMPETENCIES

  • Self-motivated individual
  • Good attention to detail and complete adherence to procedures
  • Ability to execute activities following direction
  • Excellent behaviour and demeanour in a cleanroom environment
  • Experience of working in a busy team and demanding environment