Senior Biopharmaceutical Commissioning Specialist

3 weeks ago


Boulder, Colorado, United States MMR Consulting Full time

Job Summary:

We are seeking a highly experienced Bioprocess Commissioning and Qualification Engineer to join our team at MMR Consulting. In this role, you will work on the commissioning, qualification, and startup of upstream and downstream bioprocess systems/equipment in the biopharmaceutical industry.

Key Responsibilities:

  • Provide technical guidance during commissioning, qualification, and start-up of various equipment and facilities.
  • Lead the development of key qualification deliverables during the project lifecycle.
  • Lead qualification processes, 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.

Requirements:

  • 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, including Risk-Based Commissioning & Qualification approaches.

Preferred Qualifications:

  • Experience with commissioning and qualification of biotech process equipment, such as fermentation, bioreactors, downstream purification processes.
  • Experience with commissioning & qualification of process control systems and building automation systems.

What We Offer:

  • Opportunity to work on high-profile projects in the biopharmaceutical industry.
  • Collaborative and dynamic work environment.
  • Professional development and growth opportunities.


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