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Biopharmaceutical Commissioning and Qualification Engineer
Biopharmaceutical Commissioning and Qualification EngineerMMR Consulting Inc • Vacaville, CA, United States
Biopharmaceutical Commissioning and Qualification Engineer

Biopharmaceutical Commissioning and Qualification Engineer

MMR Consulting Inc • Vacaville, CA, United States
1 day ago
Job type
  • Full-time
Job description

Join Our Team!

Your Expertise is Essential!

MMR Consulting is an engineering and consulting firm leading the way in the pharmaceutical and biotechnology sectors. We are excited to bring on a dedicated Biopharmaceutical Commissioning and Qualification Engineer who brings invaluable experience from the pharmaceutical or biotech field.

This is an amazing opportunity to be part of our expanding team, working alongside skilled engineers and specialists focused on project management, commissioning, and qualification of cutting-edge equipment and systems. The role will be carried out at client facilities in Vacaville, California.

Your Role and Responsibilities :

  • Provide expert technical guidance for the commissioning, qualification, and start-up of essential equipment and facilities utilized in life science manufacturing, including bioreactors, tanks, and sterilization equipment.
  • Lead the creation of critical qualification deliverables throughout the project lifecycle, ensuring clarity and relevance of the action plans.
  • Oversee the qualification processes such as VPP, Risk Assessments, and various qualifications (DQ, FAT, SAT, IQ, OQ, PQ) to ensure timely and quality-driven project completion.
  • Prepare and execute protocols, analyze data, resolve deviations, and compile final reports with precision.
  • Coordinate and facilitate cross-functional meetings to drive project progress and support decision-making.
  • Engage with various departments for effective design reviews and decisions.
  • Occasional travel may be required for client meetings, vendor coordination, or Factory Acceptance Testing (FAT).
  • Client relationship management, project scheduling, and budgeting to ensure successful delivery of services and support the pursuit of new opportunities.
  • Conduct site visits while adhering to all safety requirements.
  • Perform additional duties as assigned in response to workload and project needs.

Your Qualifications :

  • 3-6+ years of hands-on experience in commissioning, qualification, or validation roles within the pharmaceutical / biotech industries.
  • A degree in Engineering or Science, ideally in Mechanical, Electrical, Chemical, Biochemical, Electromechanical, or a related discipline.
  • Outstanding written and verbal communication skills, with the ability to produce high-quality technical documentation.
  • Thorough understanding of cGMP operations and related compliance areas including SOPs and Validation.
  • Experience in executing validation projects is preferred; knowledge of Risk-Based approaches like ASTM E-2500 or ISPE ICQ is a plus.
  • Familiarity with biotech process equipment and upstream or downstream processes (fermentation, chromatography, TFF) is crucial.
  • Experience with commissioning and qualification of process control systems and building automation systems is advantageous.
  • Ability to lift up to 50 lbs and manage multiple projects in a dynamic work environment.
  • Strong multitasking capabilities are essential.
  • Competitive Salary : $80,000 - $120,000 based on experience.

    Equal Employment Opportunity :

    MMR Consulting is proud to be an equal opportunity employer. We embrace diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are made based on merit, qualifications, and business needs. We are dedicated to providing reasonable accommodations to individuals with disabilities globally. If you require reasonable accommodation during the application or interview process due to a medical condition or disability, please let us know.

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    Commissioning Engineer • Vacaville, CA, United States

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