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.
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.
- 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.
- 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.
- 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