Senior Pharmaceutical Engineer
4 days ago
Optimus Life Sciences is a top-ranking company in High-Tech Pharmaceutical Engineering. We are seeking an experienced CQV Engineer to join our team in Copenhagen, Denmark.
About the Role:
This is a mid-senior level position that requires strong technical skills and experience in commissioning and qualification of process systems and equipment in production areas within the pharmaceutical or biotechnological environment. The successful candidate will have excellent communication skills and be able to work effectively with different departments.
Responsibilities:
- Perform practical CQV tasks following the documentation phase.
- Carry out the commissioning of various process and utility systems, covering upstream and downstream processes/utilities, as well as clean and black utilities.
- Take responsibility for organizing and coordinating all actions needed to maintain GMP compliance for the engineering department. Also, plan and assist in qualifying process equipment and process plants in production areas.
- Conduct IQ/OQ testing on upstream and downstream equipment/instrumentation.
- Ensure timely completion of assigned work within the project schedule, while adhering to engineering design standards and demonstrating equipment operability.
- Assist other departments with the preparation and implementation of machine acceptance tests, and provide guidance for CQV activities at the site level.
Requirements:
- Preferably hold a university degree in pharmaceutical engineering, biotechnology or process engineering or a comparable subject.
- If you don't have a degree, several years of professional experience in the field of commissioning/qualification/validation under GMP are desirable with process systems and process equipment in production areas in the pharmaceutical or biotechnological environment.
- Experience working with upstream/downstream processes and equipment, clean and black utilities, and HVAC.
- Ability to work with different departments.
- Independent and proactive approach to hands-on activities.
- Fluency in English.
About Us:
Optimus Life Sciences is a leading company in High-Tech Pharmaceutical Engineering.
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