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 commercialise two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19. 

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 650 employees.

As we continue to expand our business in Livingston, we are looking for a QC Assistant to support the Quality Control team in Livingston based on a 12 month fixed term contract.

Job Responsibilities

  • Maintain adequate stocks of materials and equipment and laboratory consumables.
  • Assist in monitoring and maintaining calibration status of all equipment within the  Quality Control department
  • Calibration of pipettes and informing relevant personnel in a timely manner of any failure of calibration
  • Assist in ensuring adequate stocks of material and equipment for effective operation of laboratories
  • Carry out general maintenance and housekeeping and cleaning of equipment and laboratories
  • 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 (e.g. scanning and archiving) duties as required by the QC Manager
  • Provide cover for other departments within the organisation
  • To undertake any other duties as requested by the QC Manager in accordance with Company requirements

Experience

  • Proven track record of being able to maintain the highest standards of hygiene and cleanliness in a laboratory environment
  • All round experience of working within a laboratory environment

Required Skills

  • Well organised, self-motivated individual
  • Ability to follow instructions and manage workload to meet expected work schedules
  • Flexible and adaptable team player

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

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 Quality Control Technicians (Analytical) to join our team in Livingston, Scotland.

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 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.

Your responsibilities as a Sample Manager Quality Control

  • Responsible for sample management for in-house and external release and stability testing for QC departments
  • Organization of Incoming and Outgoing Shipments (Supply Coordinator)
  • Samples storage and distribution for internal testing
  • Maintain oversight and coordination of external testing
  • Maintain communication/contact with external and internal clients
  • Responsible for Purchase Order processing
  • Establishment of in house testing schedule and Certificates of Analyses
  • Archiving/filing of documents according to GMP requirements
  • Support basic lab equipment maintenance and calibration activities

Your qualifications

  • Bachelor/HTL degree in natural sciences
  • Excellent organizational, documentation management and teamwork skills required
  • High communicational skills required
  • Working experience in a laboratory or quality (GxP) environment is a plus
  • English fluently in word and writing, Experience with Word and Excel
  • Management and consolidation of large data sets/lists
  • Highly team-orientated personality
  • Willing to work in a high-quality regulated GxP environment

Our offer

  • Open, appreciative company culture with innovative spirit and attractive assignments
  • International surrounding with flat hierarchies
  • Good team spirit in a strong and highly motivated team
  • Wide range of benefits

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 34.000,- gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.