Biopharmaceutical Commissioning and Qualification Engineer
4 days ago
We are seeking a highly skilled Biopharmaceutical Commissioning and Qualification Engineer to join our team at MMR Consulting. As a key member of our engineering team, you will be responsible for leading the commissioning, qualification, and start-up of various equipment and facilities in the biopharmaceutical industry.
Key Responsibilities- Provide technical guidance and leadership in the commissioning, qualification, and start-up of equipment and facilities.
- Develop and execute qualification plans, protocols, and reports to ensure timely completion and adherence to quality and engineering specifications.
- Coordinate with cross-functional departments to drive project progress, facilitate decisions, and provide updates.
- Engage with clients, vendors, and contractors to ensure effective project delivery.
- Supervise contractors during critical testing of systems and equipment.
- Perform other duties as assigned by the client and/or MMR Consulting.
- 8+ years of experience in commissioning, qualification, or validation of various systems within the pharmaceutical/biotech industry.
- 6+ years of direct C&Q experience with upstream or downstream bioprocess equipment/systems.
- Knowledge of cGMP operations, including SOPs, Change Controls, and Validation.
- Experience with developing and executing validation projects, including Risk-Based Commissioning & Qualification approaches.
- Leadership skills to lead/mentor intermediate/junior engineers.
- Ability to lift 50 lbs.
- Engineering or Science degree, preferably in Mechanical, Electrical, Chemical, Biochemical, Electromechanical, or a related discipline.
- A dynamic and growing team in the pharmaceutical and biotechnology industries.
- Opportunities for professional growth and development.
- A collaborative and inclusive work environment.
- Competitive compensation and benefits package.
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