Commissioning & Qualification Engineer - API - Pharmaceutical

Job type:
Start date:
Quanta Consultancy Services
South East
Published at:
flag_no United Kingdom
Contact person:
Lee Mitchell
Project ID:

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Experienced Commissioning & Qualification Engineer is required for a long term contract position based in the South East.

Working on a new build API manufacturing facility, you will be required to act as the client representative, overseeing the engineers on site, ensuring CQV activities are compliant and in accordance to the client's requirements.

Key Responsibilities will include:-
• 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:

• 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).
• Degree or HNC/D qualified in an Engineering-based subject or related experience in an Equipment/Commissioning/Validation role.
• Compilation and development of associated Commissioning, Qualification and Validation documentation in line with GMP standards.