Biopharmaceutical Systems Engineer
3 weeks ago
C&Q Engineer
About the Role:We are seeking an experienced C&Q Engineer to lead the commissioning, qualification, and start-up of upstream and downstream bioprocess systems/equipment in the biopharmaceutical industry. In this role, you will provide technical guidance and lead the development of key qualification deliverables throughout the project lifecycle.
Key Responsibilities:- Develop and implement commissioning plans to ensure timely completion and adherence to quality and engineering specifications.
- Lead qualification processes, including VPP, Risk Assessments, RTM, FCCA/dRA, DQ, FAT, SAT, IQ, OQ, and PQ as appropriate.
- Prepare protocols, execute protocols, summarize data, resolve deviations, and prepare final reports.
- 8+ years of experience in commissioning, qualification, or validation of various systems within the pharmaceutical/biotech industry.
- Minimum 6 years should include direct C&Q experience with upstream or downstream bioprocess equipment/systems.
- Excellent written and spoken English is required, including the preparation of technical documents in English.
- Knowledge of requirements for a cGMP operations, including SOPs, Change Controls, Validation.
MMR Consulting Inc offers a competitive salary range of $120,000 - $180,000 per year, depending on experience.
About MMR Consulting Inc:MMR Consulting Inc is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Our services include Engineering, Project Management, and other Consulting services.
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