CQV Engineer - Bielefeld, Germany - 12+ Months

Optimus Life Sciences; Bielefeld; Vor Ort; EUR 50.000 - 80.000; Vollzeit

Zusammenfassung

An innovative firm in the biotech sector is seeking a skilled CQV Engineer to join their dynamic team in Bielefeld. This exciting role involves planning and executing CQV activities, developing protocols in compliance with cGMP, and collaborating with cross-functional teams to ensure project success. With a focus on quality and compliance, you'll gain valuable experience in a fast-paced environment that fosters growth and development. If you're ready to make a significant impact in the pharmaceutical engineering field, this opportunity is perfect for you.

Qualifikationen

• Experience in CQV within a regulated industry like pharmaceuticals.
• Working knowledge of cGMP, GAMP, FDA, and EMA guidelines.

Aufgaben

• Plan and execute CQV activities for utility, process, and facility systems.
• Document CQV activities and maintain data integrity.

Kenntnisse

CQV Engineering

cGMP Knowledge

Problem-Solving Skills

Communication Skills

Documentation Skills

Ausbildung

Bachelor's Degree in Engineering

Bachelor's Degree in Life Sciences

Tools

e-validation platforms

Jobbeschreibung

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.

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!