C& Q Engineer- Biopharma

Job type:
on-site
Start:
n.a
Duration:
n.a
From:
Quanta Consultancy Services
Place:
North West
Date:
07/29/2015
Country:
flag_no United Kingdom
project ID:
954691

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This project is archived and not active any more.
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We have two new urgent requirements  for a leading biopharma company in the North West. These requirements come during a series of new capital investment projects on site and a recent GAP analysis, where significant  improvements are required. 



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.

- 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.



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 Biopharmaceutical manufacturing environment responsible for commissioning,   qualification and process qualification of equipment.

- Equipment to include: Sterilisers, Lyophilisers, Depyrogenation tunnels, Isolators – Filling line. Utilities experience with HVAC and CIP would be beneficial.

- 7-10 years’ experience in process commissioning & qualification in the Biotech/pharmaceutical industry.

- Familiarity with unit operations involved in the manufacture of Biopharmaceutical products. compilation and development of associated Commissioning, Qualification and Validation documentation in line with GMP standards



Please apply now for these excellent, potentially long term roles with a market-leading company.