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Senior Commissioning and Qualification Engineer
2 weeks ago
Previous Pharmaceutical/Biotech experience is mandatory for this role.
MMR Consulting is an engineering and consulting firm that specializes in the pharmaceutical and biotechnology industries, offering services in Engineering, Project Management, and Consulting.
This is a fantastic opportunity to be part of our dynamic team in the San Francisco Bay Area. Here, you will collaborate with skilled engineers and specialists involved in project management, commissioning, and qualification of state-of-the-art equipment, systems, and facilities in the biopharmaceutical sector.
The ideal candidate for the Senior Bioprocess C&Q Engineer role will lead the commissioning, qualification, and startup of crucial upstream and downstream bioprocess systems, delivering exceptional results in the rapidly evolving biopharmaceutical industry while providing mentorship to junior engineers.
Responsibilities
- Provide expert technical support for the commissioning, qualification, and startup of various life science manufacturing equipment and facilities, including but not limited to bioreactors, tanks, and purification systems.
- Lead and develop key qualification deliverables throughout the project lifecycle to ensure clarity and relevance in action plans for testing systems.
- Oversee qualification processes across the project lifecycle, including VPP, Risk Assessments, RTM, DQ, FAT, SAT, IQ, OQ, and PQ, ensuring timely delivery and compliance with quality and engineering specifications.
- Prepare and execute detailed protocols, summarize data, resolve deviations, and compile comprehensive final reports.
- Experience with the commissioning and qualification of process equipment and utilities is valuable, and thermal validation experience is a plus.
- Facilitate cross-functional meetings to drive project progress, aid decision-making, and provide updates.
- Work collaboratively with other departments for design reviews and decisions.
- Occasional travel may be required for client meetings, vendor engagements, or Factory Acceptance Testing (FATs).
- Be available to provide support during shutdowns or extended hours, particularly during the installation and validation phases.
- Establish and maintain strong client relationships to support business development and new project pursuits, including technical support for proposals, presenting at industry conferences, and publishing papers.
- Conduct visits to construction and installation sites while adhering to all safety requirements.
- Perform other duties as assigned by clients or MMR, based on workload and project requirements.
Qualifications
- 8-12+ years of experience in commissioning, qualification, or validation within the pharmaceutical or biotech sectors.
- Excellent command of written and spoken English, including the ability to prepare technical documents.
- In-depth knowledge of cGMP operations requirements, encompassing SOPs, Change Controls, and Validation protocols.
- Experience with developing and executing validation projects; familiarity with Risk-Based Commissioning & Qualification approaches such as ASTM E-2500 or ISPE ICQ is advantageous but not required.
- Proven experience with the commissioning and qualification of biotech process equipment, including fermentation and downstream purification processes.
- Experience with process control systems and building automation systems is advantageous but not essential.
- Knowledge of qualification or validation of clean utilities, ISO clean rooms, and thermal validation is a plus.
- Proficiency in preparing and executing URS, DQ, RTM, Risk Assessments, CPPs, VPPs, FAT, SAT, IOQ, NCRs, and Final Reports.
- Physical ability to lift up to 50 lbs.
- Degree in Engineering or Science, preferably in Mechanical, Electrical, Chemical, Biochemical, Electromechanical, or a related field.
- Ability to manage multiple projects effectively in a fast-paced environment.
- Strong multi-tasking capabilities.
Salary range: $100,000 - $145,000 based on experience.
Equal Employment Opportunity and Reasonable Accommodations
MMR Consulting is an equal opportunity employer. We embrace diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based solely on merit, qualifications, and business needs. We are dedicated to providing reasonable accommodations to individuals with disabilities worldwide. If you require a reasonable accommodation due to a medical condition or disability during the application or interview process, please inform us of your request.
