CQV Engineer - Bielefeld, Germany - 12+ Months
I am looking for an experienced CQV Engineer who is interested in working for one of the top-ranking companies in High-Tech Pharmaceutical Engineering. Join a team of hard-working Engineers in Bielefeld, Germany and gain valuable experience working on an exciting project in the biotech sector.
Title:
CQV Engineer
Location :
Bielefeld, Germany
Positions Available:
1
Type:
Contract (12+ Months)
Your Responsibilities:
* Plan, coordinate, and execute CQV activities for utility, process, and facility systems.
* Develop, review, and execute protocols (IQ, OQ, PQ) in accordance with current Good Manufacturing Practices (cGMP) and project requirements.
* Support commissioning efforts, including functional and performance testing of equipment and automated systems.
* Participate in walkdowns, punch list resolution, and verification of system readiness.
* Conduct testing of control logic, alarms, interlocks, and system responses as part of automation and process validation.
* Document all CQV activities clearly and accurately, maintaining data integrity and audit readiness.
* Collaborate with engineering, quality, operations, and project management teams to resolve technical issues and ensure compliance with project goals.
* Assist in the development of system lifecycle documentation including URS, FS, DS, and traceability matrices.
* Support deviation investigation, change control, and CAPA processes related to CQV activities
Your Requirements:
* Bachelor’s degree in engineering, life sciences, or a related field.
* Experience in CQV within a regulated industry (e.G., pharmaceutical, biotechnology, medical devices, etc.).
* Working knowledge of cGMP, GAMP, FDA, EMA, or relevant regulatory guidelines.
* Familiarity with commissioning tools and electronic documentation systems (e.G., e-validation platforms).
* Strong understanding of automated control systems and process instrumentation.
* Excellent problem-solving, communication, and documentation skills.
* Ability to work both independently and collaboratively in a fast-paced project environment.
If you are interested in this role, please do not hesitate to send me your CV today for an immediate response!
mbernhard@optimussearch.com