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