Description
Biopharmaceutical Manufacturer currently haS a long term contract requirement for an experienced Commissioning & Qualification Engineer.Working as part of a project team, you will be required to carry out the commissioning and qualification of the buffer preparation equipment - bioreactors, vessels, agitators including creation of the documentation - IQ/OQ/PQ/SOP'S ETC
The successful candidate will be able to demonstrate a proven track record, to take systems from the Construction Handover stage and carry them through the Commissioning and Validation cycle and into Performance Qualification to allow handover to Manufacturing.
You will have excellent communication and interpersonal skills to work within a team of Commissioning and validation engineers, and work closely with a cross-functional team and coordinate activities between Manufacturing, Quality and Validation
RESPONSIBILITIES
Oversee the generation, execution and approval of Commissioning & Qualification documentation.
Generate change controls and drive their closure in a timely manner
Responsibility for direct supervision of vendor engineers and contractors during C&Q activities.
Use of permit to work system or other safety systems to control commissioning activities.
Participation in HAZOP and design reviews
Deliverables such as technical specifications and vendor turnover documentation
SCOPE
C&Q Engineer has scope to initiate process, cost and continuous improvement ideas.
EDUCATION AND EXPERIENCE REQUIRED:-
Minimum of an Engineering Degree with 6+ years experience working as a C&Q engineer in a Bio-Pharmaceutical or equivalent type industry
Demonstrated experience in leading qualification systems
Need to have written and executed documentation - IQ, OQ, SOPs etc
Technical knowledge of working within a biopharmaceutical environment, with previous buffer prep experience,biotechnology processes and a working knowledge of FDA and EU regulations is essential