Biopharmaceutical Validation Engineer Leader

5 days ago


Durham, North Carolina, United States MMR Consulting Full time
Job Overview

MRR Consulting is a leading engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Our services include Engineering, Project Management, and other Consulting services.

We are seeking an experienced Biopharmaceutical Validation Engineer to lead our team of validation engineers and specialists. The successful candidate will work on the validation of upstream and downstream bioprocess systems/equipment in the biopharmaceutical industry, as well as process equipment in pharma/biotech industries.

Key Responsibilities
  • Provide technical guidance into the commissioning, qualification and start-up of various pharmaceutical / biopharmaceutical cGMP process equipment, utilities & facilities.
  • Lead the development of key qualification deliverables such as DQ, FAT, SAT, IQ, OQ and PQ during the project lifecycle.
  • Able to perform field execution of qualification test cases and protocols.
  • Support development of Project Validation Plans (PVPs) to ensure the action plan to test the system is applicable and relevant.
  • Lead qualification processes throughout the project lifecycle to ensure timely completion and to ensure all quality and engineering specifications are met.
Requirements
  • 12+ years of experience in commissioning, qualification, validation of various systems within the pharmaceutical/biotech industry.
  • Experience with commissioning & qualification of equipment & facilities is required.
  • Validation experience such as cleaning validation, thermal validation, mixing studies, process validation, computer systems validation is an asset but not required.
  • Leadership skills to lead/mentor intermediate/junior engineers.
About Us

MRR Consulting is committed to creating an inclusive environment for all employees. We celebrate diversity and are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If you need a reasonable accommodation for any part of the application or interview process, please let us know.

What We Offer
  • $120,000 - $150,000 per year, depending on experience.
  • A competitive benefits package including health insurance, retirement savings, and paid time off.
  • Opportunities for professional growth and development.
  • A collaborative and dynamic work environment.


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