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

Job Summary

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

Primary functions of the job are to:

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

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

Responsibilities

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

Job Requirements

Experience

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

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

Required Skills

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

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

 

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.

An opportunity has arisen in Livingston for multiple Manufacturing Technicians.  Initially working on a Mon – Fri dayshift, we will extend to become a 24/7 manufacturing operation at some point in mid-2021.  We are asking your shift preferences so that we can discuss potential working patterns based on the various information provided.

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 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