\\nMain Responsibilities:

• Planning, coordination and execution of all phases for commissioning and qualification of GMP manufacturing systems according to local and global procedures and standards as well as legal requirements
• Facilitating the development, performing review and approving technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation)
• Development of C&Q verification documents including but not limited to Commissioning/ Qualification plans, FMEA, IQ, OQ as well as for the execution of verification activities
• Coordination and oversight of vendor FAT/SAT, commissioning activities in collaboration with internal and external partners
• Planning and execution of qualification activities regarding production equipment, QC and infrastructure
• Assessing and handling of Change Controls, CAPAs and Non-Conformances related to qualification topics

Our Requirements:

• Bachelor/Master degree in engineering discipline (chemical and mechanical engineering)
• Proven work experience(3-5 years) in biotech or pharma company in an cGxP environment and/or C&Q equivalent position
• Good written and spoken skills in English, German is a plus.
• Experience and knowledge in sterilization cycle development, smoke study, technical air measurement, cleaning validation, and temperature/humidity mapping
• Know-how of Commissioning and Qualification requirements according to cGMP regulations
• Excellent knowledge and experience in Downstream processing (DSP)
• Analytical thinking and problem-solving ability; strong attitude on working collaboratively with all stakeholders to ensure that activities are planned and delivered in an most efficient timeframe
• Excellent team player with self-management skills

Do you want to join our mission in a motivated team? Please submit your application to\\n \\n \\n \\n \\n \\n

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