Technical Qualification Project Manager

Proclinical is seeking a Technical Qualification Project Manager for a consulting company, to be based in Munich on a permanent basis. In this full-time role, the person will be responsible to work in different projects related to Technical Qualification and Engineering. The person will work alone or more frequently coordinating multidisciplinary teams.

Job Responsibilities:

• Development of qualification plans, user/technical requirements specifications, design qualification reports, test plans, requirements-testing traceability matrixes, qualification summary reports
• Development of installation, operational and performance qualification protocols for equipment and utilities (e.g.: HVAC, Water Systems, Process Gases), according to the current internationally recognized guidelines (e.g.: ISPE, GAMP)
• Development of thermal validation study protocols
• Development of project validation master plans for new sites implementation including detailed Gantt charts with predecessors and resources workload evaluation (advanced knowledge of Microsoft Project requested)
• Knowledge of the main test instruments suites (e.g.: GE Kaye Validator, Thermal validation studies data loggers, HVAC test instruments, calibration instruments)
• Coordination of junior resources for qualification testing execution and use of test instruments
• Development of risk-based assessment at process, component and functional level according to the internationally recognized methodologies (e.g.: FMEA, HACCP)
• Development of calibration and maintenance plans and related instructions
• Development of standard operating procedures
• Advanced knowledge of EU and US GMP

Skills and Requirements:

• Fluent German and English (Mandatory)
• Technical Degree (Engineering, Chemistry, Informatics, Physics, Mathematics)
• Minimum of 3 years' experience in the drug manufacturing area
• Availability to travel (Mandatory)
• Integrity, strong analytical skills and attention to detail
• Fluent in other languages
• PhD in technical fields

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nick Dietz on +44 203 3193 033 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

#LI-ND1