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 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