With continued organisational growth and a considerable amount of investment across the portfolio and capital programme.
They are seeking the expertise of a Process Engineer.
Essential Duties and Responsibilities for this xxxx role include, but are not limited to, the following:
- Resource to work with existing site engineers to perform feasibility studies as well as cycle development work under Engineering Studies (formal protocols).
- Protocol development, execution of testing to define process parameters/capability to include recipe development and CPP/KPP identification.
- Perform review of CQV protocols at each stage of the validation life cycle from design and risk assessment through to qualification and validation.
- Provide up to date information to Line Management on activities and timelines relating to validation work, utilising appropriate techniques.
- Have a solid understanding of mechanical systems, system controls and instrumentation. Personnel will report on project status and update project management on weekly deliverables. Will participate in project/site meetings and provide team updates as needed.
- Experience within Biotech/pharmaceutical Manufacturing environments with a specific background in Biologics sterile/aseptic fill finish
- Solid experience of project lifecycle activities to include the qualification of equipment in conjunction with Project engineering/CAPEX teams.
- Demonstrable experience in drafting, executing and reporting of documentation ie IQ, OQ, PQ protocols.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
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