CQV Engineer

Opdrachtgever

Our client is a leading consulting and engineering firm in pharma, food and chemistry.

Bachelor’s degree in Engineering, Science or related technical field.
Proficient with computers (MS Office). Solid understanding of controlled documentation and data systems.
In-depth knowledge of cGMP regulations.
5+ years of experience within a GMP environment, preferably within the biotech industry.
3+ years of experience with CQV.
Flexible, a team player, a problem solving mindset and positive attitude.
Customer and result-oriented.
Forward-looking attitude and engaging cooperative style.
Good communication and interpersonal skills.
Needs to have an European passport.

Accountable for all aspects of CQV activities as required by schedule and project timelines.
Design, develop, execute, write and archive C&Q documentation, such as systems commissioning, IQ, OQ, PQ and validation protocols and reports.
Analyse and interpret validation data and results, and summare findings in final reports.
Analyse the design to identify the GMP requirements for validation.
Resolve protocol and execution discrepancies, finding a satisfactory conclusion and plan follow-up actions as required.
Conduct and coordinate validation testing.
Maintain good contact with team members, sharing knowledge, and troubleshooting.