Biopharmaceutical Commissioning Specialist
1 week ago
MMR Consulting Inc is seeking a highly skilled Biopharmaceutical Commissioning Specialist to join our team. As a Biopharmaceutical Commissioning Specialist, you will be responsible for providing technical guidance and expertise in the commissioning, qualification, and start-up of various equipment and facilities in the biopharmaceutical industry.
Key Responsibilities:- Provide technical guidance and expertise in the commissioning, qualification, and start-up of various equipment and facilities.
- Lead the development of key qualification deliverables during the project lifecycle.
- Execute qualification processes throughout the project lifecycle, including VPP, Risk Assessments, RTM, FCCA/dRA, DQ, FAT, SAT, IQ, OQ, and PQ.
- Prepare protocols, execute protocols, summarize data, resolve deviations, and prepare final reports.
- Coordinate meetings with cross-functional departments to drive project progress and facilitate decisions.
- Supervise contractors during critical testing of systems and equipment.
- 6+ years of experience in commissioning, qualification, or validation of various systems within the pharmaceutical/biotech industry.
- Excellent written and spoken English is required, including the preparation of technical documents.
- Knowledge of requirements for cGMP operations, including SOPs, Change Controls, and Validation.
- Experience with developing and executing validation projects, including Risk-Based Commissioning & Qualification approaches.
- Experience with commissioning & qualification of process control systems and building automation systems.
MMR Consulting Inc offers a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced Biopharmaceutical Commissioning Specialist looking for a new challenge, please submit your application.
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