Biopharmaceutical Senior CQV Engineer
2 days ago
MRR Consulting Inc is seeking a highly skilled Biopharmaceutical Senior CQV Engineer to join our team. As a Biopharmaceutical Senior CQV Engineer, you will be responsible for the commissioning and qualification of various equipment and facilities in the biopharmaceutical industry.
Responsibilities:- Provide technical guidance during the commissioning and qualification of various equipment and facilities.
- Lead the development of key qualification deliverables during the project lifecycle.
- Lead 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.
- Experience with C&Q of upstream or downstream bioprocess systems is required.
- Coordinate meetings with cross-functional departments to drive project progress, facilitate decisions, and provide updates.
- Excellent written and spoken English is required.
- Years of experience: 12+ years in commissioning, qualification, or validation of various systems within the pharmaceutical/biotech industry.
- Knowledge of requirements for a cGMP operations, including SOPs, Change Controls, Validation.
- Experience with developing and executing validation projects.
- Experience with commissioning and qualification of biotech process equipment, such as fermentation, bioreactors, downstream purification processes.
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