CQV Engineer - Hamburg, Deutschland - Optimus Life Sciences

Beschreibung

Title: Senior CQV Engineer

Location: Hamburg Area, Germany

Type: Contract / Freelance (6 months+)

Responsibilities:

• Participation in the setup, commissioning, and maintenance of new installations and laboratory equipment, focusing on qualification, calibration, and technical aspects.
• Collaboration and project management in technical projects, modifications, and improvements of facilities, as well as in change control procedures.
• Contribution to the establishment/update of procedural instructions to ensure compliance with current pharmacopeial requirements and regulatory standards.
• Initiation of change control procedures and qualification activities in consultation with supervisors.
• Drafting and executing qualification documents (URS, DQ, IQ, OQ, PQ, etc.) in accordance with applicable standards in coordination with supervisors.
• Engaging in technical discussions with potential suppliers of process equipment and laboratory instruments.
• Participation in inspection readiness preparations.
• Qualification and maintenance of measuring and testing instruments.
• Qualifying existing equipment and facilities through functional testing.

Requirements:

• Engineering degree with a focus on process engineering, mechanical engineering, or a related natural or engineering science degree.
• At least 5 years of professional experience in the pharmaceutical industry and comprehensive expertise in qualification, ideally including ventilation and clean utility systems.
• Understanding of processes and technical knowledge in aseptic filling or manufacturing processes and automation, with a focus on data integrity.
• Strong sense of GMP, quality, and responsibility, including precise and careful work.
• Independent, structured, and cooperative work style.
• Excellent written and spoken German and English skills.

I am expecting a high volume of applicants for this position so please get in touch as a priority if you wish to be considered.

Please send your updated CV to