Description
A Pharmaceutical Manufacturing plant has a contract requirement for an experienced C&Q Engineer, to work as a client representative and oversee the C&Q activities of a new build project.With the equipment currently being installed, we are looking for a Commissioning & Qualification Engineer, with HVAC and API experience, to oversee the engineering firm on site, with regard to the CQV activities
This is a new build Pharmaceutical Manufacturing facility to house API/Primary pharmaceutical unit during an increased scope of demand. This is currently in the equipment fit-out phase, which is being handled by Engineering Consultancy (approaching Mechanical completion)
Key Responsibilities:
• Generation of list of C&Q tests (Installation Verification (IV), Operational Verification (OV), Operational Qualification (OQ), Performance Testing (PT) and Performance Qualification (PQ).
• Execution of process commissioning & qualification tests in adherence with project schedule.
• Retain sole ownership and responsibility for commissioning and qualification documents from generation, through pre-approval, execution, post-execution review and final sign-off.
• Acting as the interface between the client and the designated Engineering company who are handling the activities up to OQ.
• Supporting process validation activities and CIP/Cleaning verification during the handover/Operational period.
Ideal Skills and Experience:
• Degree or HNC/D qualified in an Engineering based subject or related experience in an Equipment/Commissioning/Validation role.
• Experience within Primary API manufacturing environment responsible for commissioning, qualification and process qualification of equipment to include Pan-dryer, Wipe film evaporator, Super critical extraction, Mobile vessels and filtration vessels.
• 7-10 years’ experience in process commissioning & qualification in the chemical/pharmaceutical industry.
• 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.