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