Validation Engineer

1 week ago

Walton, United Kingdom PE Global Full time

**PE Global are looking for a Validation Engineer (Associate/Junior level) to support ongoing projects for a leading Animal Health GMP regulated multinational company based in Walton, Buckinghamshire.**

The Associate Validation Specialist role is set within the Validation Department, part of the Engineering function.

**Key Responsibilities**
- Developing and executing validation plans for projects and modifications to processes, equipment, utilities, computer systems and facilities.
- Ensuring adherence to the requalification plan to maintain compliance.
- Writing, reviewing and approving validation protocols, SOPs and other documentation.
- Raising and completing CAPAs and deviations; supporting investigations into events as required.
- Providing technical input into gap assessments, Product Quality Reviews and Quality Risk Assessments.
- Participating in asset reliability reviews.
- Any other works, as required, to support the Validation and Engineering teams.

**Key Skills**:

- Demonstrated experience of varied validation and requalification activities such as:

- Autoclaves
- HVAC, including HEPA filter testing
- Clean rooms, Isolators, biological safety cabinets, fume hoods and downflow booths
- Airflow visualization studies
- Vessels, pipework and sterile components
- Manufacturing processes
- Software, including spreadsheets
- Cleaning (CIP, parts washers and manual cleaning processes)
- Utilities (including steam, compressed air, nitrogen, purified water, water for injection)
- Laboratory test methods
- Controlled temperature units (including fridges, freezers, incubators, cold rooms)
- Computerised systems
- Experience of using various validation equipment items, such as Kaye validators and Valprobes, Yokogawa data loggers, DOP testing equipment, anemometers, and balometers.
- Understanding of cGMP, including good documentation practices
- Attention to detail, ability to review and correct technical documentation

**Required Experience**
- BSc or MSc in a Science or Engineering related discipline
- A minimum of 2 years working in a validation, quality, production or engineering role within the pharmaceutical industry.
- Management of external contractors

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