CQV Engineer

Title: Senior CQV Engineer

Location: Hamburg Area, Germany

Type: Contract / Freelance (6 months+)

Responsibilities:

• Assist in setting up, operating, and maintaining new facilities and lab equipment, focusing on qualification and technical aspects.
• Lead technical projects, modifications, and improvements of facilities, including change control.
• Initiate and execute change control procedures and qualification activities.
• Create and execute qualification documents in line with norms and standards.
• Engage in technical discussions with equipment suppliers.
• Prepare for inspections and support qualification assignments.
• Ensure high availability of facilities/equipment.
• Drive process improvements and standardisations.
• Maintain and qualify measuring/testing instruments.
• Execute GMP-compliant requalification activities.
• Collaborate with project teams, particularly Construction Management.

Requirements:

• Degree in engineering with a focus on process engineering, mechanical engineering, or a related natural or engineering science field
• Several years of professional experience in the pharmaceutical industry with extensive expertise in qualification, ideally also in ventilation and cleanroom systems
• Proficient in project management with experience in participating in projects
• Understanding of processes and techniques in aseptic filling and manufacturing as well as automation, considering data integrity aspects
• Strong GMP, quality, and responsibility awareness with precise and meticulous work habits
• Independent, structured, and cooperative work style
• Excellent proficiency in both spoken and written German and English
• Willingness to undertake occasional business trips

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 ccorremans@optimussearch.com.