Description
A large pharmaceutical company is going through an exciting period of growth, with a peak in project activity as they look to expand production for a groundbreaking drug, and are looking for a CQV Engineer to assist with operations on site.On an initial 6 month contract, focus will be given to a shutdown operation and the installation of new equipment - with phased released of the qualified and validated equipment to run until at least the end of the year.
Responsibilities:
- Generation of C&Q tests (Installation Verification (IV)/Installation Qualification (IQ), Operational Verification (OV), Operational Qualification (OQ), Performance Testing (PT) and Performance Qualification (PQ).
- Execution of process commissioning & qualification tests in adherence with the project schedule.
- Retains sole ownership and responsibility for commissioning and qualification documents from generation, through pre-approval, execution, post-execution review and final sign-off.
- Supporting process validation activities and CIP/Cleaning verification during the handover/Operational period.
- CIP Qualification responsibility.
- Experience within Pharmaceutical/Primary API manufacturing environment - responsible for commissioning, qualification and process qualification of equipment.
- Familiarity with unit operations involved in the manufacture of active pharmaceutical ingredients (API's).
- Compilation and development of associated Commissioning, Qualification and Validation documentation in line with GMP standards.
- Delivery of IQ, OQ and PQ as well as the execution and follow through.