Biopharmaceutical Commissioning Specialist

1 week ago


Austin, Texas, United States MMR Consulting Inc Full time
Job Title: Biopharmaceutical Commissioning Specialist

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.
Requirements:
  • 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.
What We Offer:

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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