Biopharmaceutical Commissioning and Qualification Engineer

4 days ago


Carlsbad, United States MMR Consulting Full time
Job Summary

We are seeking a highly skilled Biopharmaceutical Commissioning and Qualification Engineer to join our team at MMR Consulting. As a key member of our engineering team, you will be responsible for leading the commissioning, qualification, and start-up of various equipment and facilities in the biopharmaceutical industry.

Key Responsibilities
  • Provide technical guidance and leadership in the commissioning, qualification, and start-up of equipment and facilities.
  • Develop and execute qualification plans, protocols, and reports to ensure timely completion and adherence to quality and engineering specifications.
  • Coordinate with cross-functional departments to drive project progress, facilitate decisions, and provide updates.
  • Engage with clients, vendors, and contractors to ensure effective project delivery.
  • Supervise contractors during critical testing of systems and equipment.
  • Perform other duties as assigned by the client and/or MMR Consulting.
Requirements
  • 8+ years of experience in commissioning, qualification, or validation of various systems within the pharmaceutical/biotech industry.
  • 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.
  • Leadership skills to lead/mentor intermediate/junior engineers.
  • Ability to lift 50 lbs.
  • Engineering or Science degree, preferably in Mechanical, Electrical, Chemical, Biochemical, Electromechanical, or a related discipline.
What We Offer
  • A dynamic and growing team in the pharmaceutical and biotechnology industries.
  • Opportunities for professional growth and development.
  • A collaborative and inclusive work environment.
  • Competitive compensation and benefits package.


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