Senior Bioprocess Commissioning Specialist

3 weeks ago


Greenville, North Carolina, United States MMR Consulting Inc Full time
Biopharmaceutical Commissioning Expert Opportunity

At MMR Consulting Inc, we are seeking a seasoned Bioprocess Commissioning Specialist to join our team of experts in the pharmaceutical and biotechnology industries.

As a key member of our commissioning team, you will be responsible for providing technical guidance on the commissioning, qualification, and start-up of various equipment and facilities. Your expertise in developing qualification deliverables, leading qualification processes, and preparing protocols will be instrumental in ensuring project success.

About the Role:
  • Provide technical leadership in the commissioning, qualification, and start-up of upstream and downstream bioprocess systems/equipment.
  • Develop and lead qualification processes, including VPP, Risk Assessments, RTM, FCCA/dRA, DQ, FAT, SAT, IQ, OQ, and PQ, to ensure timely completion and adherence to quality specifications.
  • Prepare and execute protocols, summarize data, resolve deviations, and prepare final reports.
Requirements:
  • Demonstrate excellent written and spoken English skills, with the ability to prepare technical documents.
  • Possess at least 8 years of experience in commissioning, qualification, or validation of systems within the pharmaceutical/biotech industry.
  • Have a minimum of 6 years of direct C&Q experience with upstream or downstream bioprocess equipment/systems.
  • Show knowledge of cGMP operations, including SOPs, Change Controls, and Validation requirements.
What We Offer:
  • A competitive salary range of $120,000 - $160,000 per year, based on experience.
  • The opportunity to work with a renowned engineering and consulting firm specializing in the pharmaceutical and biotechnology industries.
  • A dynamic and supportive work environment that fosters professional growth and development.


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