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 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

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.

An opportunity has arisen in Livingston for Graduate Level Manufacturing Scientists, working a 12 hour shift based system

Job Summary

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

Key Responsibilities

  • Execute production steps defined by SOPs, production records and protocol for manufacture of a Covid vaccine
  • 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 and CAPAs in the most diligent manner
  • Identify areas for continuous improvement and escalate those to the respective manufacturing supervisor or appropriate person
  • Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team setting
  • Shift work and out of hours work as may be required
  • 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 or HNC/HND or equivalent experience
  • Experience of cell culture and aseptic technique is desirable
  • Cleanroom experience
  • Experience of working within a cGMP environment
  • Experience of following SOPs within defined cGMP work practices

Competencies

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

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.

An opportunity has arisen in Livingston for Manufacturing Process Technicians.

We are currently operating a variety of shift patterns (both 8 hour and 12 hour patterns) , all will include some form of weekend working.

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

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.

An opportunity has arisen in Livingston for Manufacturing Scientists.

We are currently looking for cover on our rotational 12 hour shift pattern, which includes night shift and weekend working.

Job Summary

The purpose of this role is to execute defined and trained manufacturing steps for the production of a COVID-19 vaccine according to set procedures and protocols and according to best cGMP work practices and Quality standards.

Key Responsibilities

  • Execute production steps defined by SOPs, production records and protocol for manufacture of a Covid vaccine
  • 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 and CAPAs in the most diligent manner
  • Identify areas for continuous improvement and escalate those to the respective manufacturing supervisor or appropriate person
  • Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team setting
  • Shift work and out of hours work as may be required
  • 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 or HNC/HND or equivalent experience
  • Experience of cell culture and aseptic technique is desirable
  • Cleanroom experience
  • Experience of working within a cGMP environment
  • Experience of following SOPs within defined cGMP work practices

Competencies

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