Facilitation of the introduction of a new product including new building, clean rooms, utilities, and multiple new production equipment and product validation
Project related to qualification and validation activities for a new production building and lines in cooperation with Engineering department, Qualification Department, Production and the Laboratories for following subprojects:
• New Building and (Clean)rooms
• Multiple new production equipment
• Manufacturing Processes
• Analytical and microbiological method
• Computer system validations
• Develop, Review and Execution of project related documentation against current GMP-requirements such as
(but not limited to):
o Planning and Design Qualification (URS, FRS, FAT, SAT) and Commissioning
o Risk Assessments (e.g. FMEA)
o Installation-, Operational- and Performance
o Documents for regulatory purposes
o Change controls, Deviations etc.
• Planning and execution of Computerized Systems Validation (CSV) in cooperation with IT and Process Automation
• Lead and participate in Risk Analysis of equipment, systems and processes
• Issue Formal Commissioning and Qualification Plans, Protocols and Reports and support different Equipment and Systems owners by providing technical knowledge
• Apply professional interdisciplinary project teamwork supporting the team with Engineering department, Qualification Department, Production, EHS in questions regarding GMP-compliant solutions
• Support root cause analyses and troubleshooting activities in case of deviations from Qualification/Validation Perspective
• Support creation, assessment, and completion of change control cases from Qualification/Validation Perspective.
• Contact to the overall project leaders in different departments and within the global project team to support project execution.
• Minimum 3 years professional experience in pharmaceutical Industry
• Exceptional knowledge in the areas of qualification and validation of building, utilities, equipment, manufacturing processes and analytical and microbiological methods
• Knowledge in automation and computer system validation
• Project management knowledge, leadership capabilities with respect to quality topics
• Experience with implementation of new pharmaceutical buildings and new line preferred
• Proficient in an English and good German language skills
Project start: Mid March / Beginning of June
Duration: 11-12 months
Availability: 4-5 days / week
Remote support: tbd.