R

Cqv engineer

Randstad

Onbekend
ongeveer 1 jaar geleden
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R

Cqv engineer

Randstad – Stein (6170)

Contract: Uren: Salaris:

Job description

Jobdescription

CQ Engineer

For our Client a biopharmaceutical company in the Aargau we are currently seeking a number of CQ engineers.The C & Q Execution Engineer is primarily responsible for the execution of the CQV activities corresponding to their project area’s equipment and processes.

 

Key Responsibilities:

  • System Boundary development + approval

  • Design Qualification preparation, execution and approval. Includes release for IQ.

  • Good Manufacturing Practice (GMP) Rapid Alert reviews

  • Commissioning preparation, execution and approval. Includes vendor supervision on their testing, scope and quality.

  • Installation Qualification preparation, execution and approval. Includes release for OQ.

  • Operational Qualification preparation, execution and approval. Includes release to OPS.

  • Provide support in execution of Design Qualification for other direct impact systems.

  • Provide support in the implementation of the installation commissioning process

 

Qualifications

  • Bachelor’s degree in Life Sciences or Engineering

  • At least 3+ years of experience in commissioning and qualification

  • Biopharmaceutical knowledge and experience

  • Specialisation in either HVAC or Clean Utilities

  • Experience with DeltaV (Emerson) and other Control Systems

  • Experience with COMOS/KNEAT platforms

  • Fluent English language written and verbal communication skills

  • cGMP knowledge and knowledge of regulatory requirements