Description
Validation engineer required for a 3-month contract in the M4 corridor for a global biotech company.Role and responsibilities:
- Contribute to the Validation Team maintaining the site compliance for GMP equipment, utilities and facilities on the Slough site.
- Prepare and execute validation protocols and reports for a range of production, laboratory equipment, facilities and utilities including controlled storage environments.
- Perform periodic reviews on equipment and systems.
- Support the site in maintaining compliance objectives through timely closure of CAPAs, Deviations, and Change Controls.
- Schedule own work and liaise with internal customers to ensure work is delivered on time and aligned with current regulatory requirements.
- Provide expert advice and support.
- Perform other duties as assigned.
- Degree level or equivalent.
- Experience: 5+ years in bio/pharmaceutical validation.
- cGMP in Bio/pharmaceuticals.
- Validation Life Cycle.
- Risk based Approach to Validation and Compliance.
- Quality systems within Bio/pharmaceuticals - CAPA, Change Control, Deviation, Non-conformance.
- Computer system validation desirable.
- Pharmaceutical equipment and systems.
- Equipment validation and qualification - delivering all aspects of validation life cycle.
- Use of temperature logging equipment, pref. Kaye Validator 2000.
- Writing and executing validation protocols, setting criteria, test methods, objectives and strategies and preparing validation reports.
- Quality decision making within a pharmaceutical environment.
- Good communicator at all levels.
- Problem solver.
- Organised - competent in planning and organising own time.
- Able to agree and meet targets.
- Able to work within a team.
- Reliable and dependable