Bioprocess Qualification Expert
1 week ago
We are seeking a highly skilled Biopharmaceutical Commissioning Engineer to join our team at MMR Consulting Inc. 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 deliverables to ensure project success.
- Lead qualification processes, including VPP, Risk Assessments, RTM, FCCA/dRA, DQ, FAT, SAT, IQ, OQ, and PQ.
- Prepare and execute protocols, summarize data, resolve deviations, and prepare final reports.
- Coordinate meetings with cross-functional departments to drive project progress and facilitate decisions.
- Engage with other departments for design reviews and decisions.
- Travel may be required for meetings with clients, equipment fabrication vendors, or Factory Acceptance Testing (FATs).
- Work may require occasional support over shutdowns or extended hours during installation and commissioning/validation phases.
- 8+ years of experience in commissioning, qualification, or validation of various systems within the pharmaceutical/biotech industry.
- Minimum 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.
- Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset.
- Experience with commissioning and qualification of biotech process equipment, process control systems, and building automation systems.
- Leadership skills, ability to take initiative, and mentorship skills to coach and develop junior and intermediate employees.
- Engineering or Science degree, preferably in Mechanical, Electrical, Chemical, Biochemical, Electromechanical, or a related discipline.
As a Biopharmaceutical Commissioning Engineer at MMR Consulting Inc, you will have the opportunity to work on challenging projects, develop your skills, and contribute to the success of our team. We offer a dynamic and inclusive work environment, competitive compensation, and opportunities for professional growth and development.
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