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 650 employees.

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

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 and 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, co-ordinate all supervisors and senior technicians to enable production plans within a shift in order to deliver product to appropriate time, quality and costs
  • Ensure that all production steps defined by SOPs, production records and protocols are being executed in compliance with cGMP standards
  • Ensure manufacturing rooms are prepared for activities and pick lists are submitted in time, to ensure the availability of raw materials.  PPRs and labels should also be available in room prior to activities commencing
  • Ensure that there are clear systems for shift handovers
  • Work in cleanrooms / supervision of activities as required
  • Ensure that all paperwork has been completed for room activities prior to staff leaving room
  • 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 of FBS qualification activities
  • Responsibility for coordination and planning of 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
  • Identify opportunities for improvements
  • Ensure that any deviations, change controls or CAPAs related to materials, facilities, processes or procedures within your shift are escalated and addressed within agreed timelines. Review and approve 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, 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
  • Complete of Goals and Objectives, 121s, mid year reviews and end of year reviews for staff, within expected timelines
  • 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 650 employees.

As part of the ongoing project in Livingston, we are now seeking interest for key roles within the Manufacturing team including Manufacturing Supervisor 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 supervision of production, production resources and will review, organise and where necessary develop systems / processes in order to achieve:

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

Responsibilities

  • On a day to day basis, co-ordinate production plans in order to deliver product to appropriate time, quality and costs
  • Ensure that all production steps defined by SOPs, production records and protocols are being executed in compliance with cGMP standards
  • Ensure manufacturing rooms are prepared for activities and that pick lists are submitted in time to ensure the availability of raw materials. PPRs and labels should also be available in room prior to activities commencing
  • Work in cleanrooms / supervise activities
  • Ensure that all paperwork has been completed for room activities prior to staff leaving room
  • Oversee that best cGMP work practices and techniques to produce product within specification are being applied, ensuring that equipment, facilities and materials used in the area of responsibility comply with defined standards
  • Ensure that all production 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 and reflect expected manufacturing techniques to remove any ambiguity in instructions
  • Responsibility for cellbank activities
  • Responsibility for FBS qualification activities
  • Responsibility for virus seedbank manufacture
  • Responsibility to motivate staff to help when there are additional pressures
  • Promptly report 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
  • Identify opportunities for improvements in upstream
  • Ensure that any deviations, change controls or CAPAs related to materials, facilities, processes or procedures are escalated and addressed within agreed timelines
  • 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
  • Complete Goals and Objectives, 121s, mid year reviews and end of year reviews for staff, within expected timelines
  • 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 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 600 employees.

An opportunity has arisen in Livingston, Scotland, 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 650 employees.

An opportunity has arisen in Livingston for Manufacturing Scientists.

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 Manufacturing Scientist

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-19 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 essential
  • 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 650 employees.

Valneva have a number of opportunities for Individuals with previous clean-room cleaning experience for our newly built manufacturing premises in Livingston, Scotland.

Job Summary Manufacturing Assistant – Cleanroom

We are looking for people to appropriately carry out all cleaning activities related to production support for ourCOVID-19 Vaccine Manufacturing Programme, according to set procedures and protocols and to best cGMP work practices and quality standards.

You will be responsible for:

  • Carrying out routine cleaning of the commercial manufacturing facility (and CTM facility as required) to a defined schedule of activities
  • Ensuring housekeeping within the cleanroom suites and common areas is maintained to a high standard at all times
  • Ensuring that response cleans are completed in a timely manner and to appropriate standards
  • Processing of orders picked from stores into the cleanroom to ensure manufacturing schedule adherence and contamination control
  • Supporting our Manufacturing activities by processing return of cleanroom garments, mops and other items as required
  • Applying best cGMP work practices and techniques
  • Immediately escalating and reporting any deviations involving materials, facilities, processes or procedures to line management
  • Conducting all activities in a careful and safe manner and in full compliance with HSE requirements
  • Supporting QMS investigations and any corrective actions and improvement opportunities
  • Identifying areas for continuous improvement and escalating those to the line manager
  • Actively contributing to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team-setting
  • Participating in training of staff in areas of expertise
  • Be flexible to work shifts and out of hours work as required
  • Undertake any other duties as requested by the line manager in accordance with company requirements

You will have:

  • A meticulous approach to all cleaning and production support activities
  • Flexibility, as there may be a variance in daily schedules from time to time
  • Previous experience of cleaning in a clean room environment (although on-going training will be provided)

Additional Required Skills

  • Excellent attention to detail
  • Ability to follow SOPs

Please Note

As this role involves working in our cleanroom environment, you will be required to undergo a Health Screening procedure with a suitably qualified Doctor as part of our recruitment process.  We also conduct a Disclosure Scotland Check on all prospective new hires.

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.

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

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 as a Quality Control Scientist

  • 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 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.

Due to the increase in business we are currently recruiting for a Stores Person to work on a 12 month fixed term contract 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 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.

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 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.

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

Job Summary Quality Control Technician

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

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.

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

Job Summary Validation Specialist

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