Are you a validation engineer looking for their next challenge?
We are supporting a leading global pharmaceutical client in their search for Validation Engineer specialising in PPQ.
Contract - 12 Months (Potential of extension)
The Validation Engineer will support new product introductions, equipment qualification, and site requalification, ensuring compliance with industry standards and regulations. This role involves ensuring ongoing validation of equipment, systems, and processes.
Main Responsibilities:
* Design, execute, and report on Process Performance Qualifications (PV) and validation studies for equipment, systems, and processes.
* Ensure validation studies meet all required standards and legal requirements (cGMP, Health & Safety, environmental, etc.).
* Provide technical guidance on FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation, and depyrogenation.
* Maintain validation documentation throughout its lifecycle.
* Support the Site Change Control process and participate in regulatory inspections.
* Experience: 3-5 years in healthcare or pharmaceutical manufacturing, including validation/product development.
* Technical Skills: Knowledge of process validation regulations, GAMP, ISPE Baseline guides, and steam/dry heat validation. Proficient in MS Project and SPC.
* Education: Degree in Chemistry, Microbiology, Pharmacy, or Engineering.
* Languages: English
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