Senior Validation Engineer for Biopharmaceuticals

5 days ago


Copenhagen, Copenhagen, Denmark Optimus Life Sciences Full time
About the Job:

We are seeking an experienced CQV Turnover Engineer to join our team at Optimus Life Sciences. The successful candidate will have a university degree in pharmaceutical engineering, biotechnology or process engineering or a comparable subject, or several years of professional experience in the field of commissioning/qualification/validation under GMP, desirable with process systems and process equipment in production areas in the pharmaceutical or biotechnological environment.

Responsibilities:
  1. Perform commissioning and qualification of various process and utility systems, including upstream and downstream processes and clean and black utilities
  2. Maintain GMP compliance for the engineering department and plan and support qualification work for process plants and equipment
  3. Ensure that IQ/OQ protocols are executed according to standard operating procedures (SOPs)
  4. Support other departments in preparing and implementing machine acceptance tests
  5. Assure that all commissioning procedures are completed to enable a smooth handover to operations
Requirements:
  • University degree in pharmaceutical engineering, biotechnology, or process engineering or equivalent
  • Professional experience in commissioning, qualification, and validation under GMP
  • Experience working with process systems and equipment in production areas in the pharmaceutical or biotechnological environment
  • Strong understanding of GMP regulations and industry standards
  • Excellent communication and teamwork skills

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