MMR Consulting
BIOPHARMACEUTICAL – SR C&Q ENGINEER
MMR Consulting, San Francisco, California, United States, 94199
Bioprocess Sr. C&Q Engineer
MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. This role is based in San Francisco Bay Area, California and focuses on commissioning, qualification, and startup of upstream and downstream bioprocess systems/equipment in the biopharmaceutical industry.
Base pay range:
$100,000.00/yr - $145,000.00/yr
Previous Pharmaceutical/Biotech experience is mandatory for this role.
This outstanding opportunity joins our growing team of engineers and specialists in project management, commissioning, and qualification. The successful candidate will work with a group of engineers and specialists involved in project management, commissioning, and qualification of equipment, systems, and facilities.
Responsibilities
Provide technical guidance for the commissioning, qualification, and startup of equipment and facilities used in life science manufacturing, such as bioreactors, tanks, CIP, buffers, media, chromatography, TFF, washers & autoclaves, etc.
Lead development of key qualification deliverables during the project lifecycle to ensure project scope is well defined and the action plan to test the system is appropriate.
Lead qualification processes throughout the project lifecycle such as VPP, Risk Assessments, RTM, DQ, FAT, SAT, IQ, OQ and PQ to ensure timely completion and compliance with quality and engineering specifications.
Experience with C&Q of process equipment, utilities, facilities is an asset. Thermal Validation experience is an asset.
Coordinate meetings with cross‑functional departments to drive project progress, facilitate decisions, and provide updates.
Engage other departments, as required, for design reviews and decisions.
Travel may be occasionally required for meetings with clients, equipment fabrication vendors or Factory Acceptance Testing (FATs).
Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning/validation phases.
Client‑management: maintain key client relationships to support business development and pursue new work, project scheduling/budgeting, coordination of client and MMR resources for effective delivery, and support business development through proposals and technical presentations at industry conferences.
Visit construction and installation sites following all site safety requirements.
Other duties as assigned by client, and/or MMR, based on workload and project requirements.
Qualifications
8–12+ years of experience in commissioning, qualification, or validation of various systems within the pharmaceutical/biotech industry.
Excellent written and spoken English, including preparation of technical documents in English.
Knowledge of cGMP operations, SOPs, Change Controls, Validation, and related regulatory requirements.
Experience with developing and executing validation projects, using risk‑based commissioning & qualification approaches such as ASTM E‑2500 or ISPE ICQ, is an asset.
Experience with commissioning and qualification of biotech process equipment (upstream or downstream, e.g., fermentation, bioreactors, chromatography, TFF, UF); required.
Experience with commissioning & qualification of process control systems (PCS, SCADA, historians) and building automation systems (Siemens Insight/Desigo, JCI Metasys) is an asset.
Experience with qualification or validation of clean utilities, ISO clean rooms, and thermal validation is an asset.
Experience preparing and executing URS’s, DQ’s, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, OQs, NCRs, and Final Reports.
Ability to lift 50 lbs.
Engineering or Science degree, preferably in Mechanical, Electrical, Chemical, Biochemical, Electromechanical or related discipline.
Ability to handle multiple projects and work in a fast‑paced environment.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Engineering, Manufacturing, and Consulting
Industries Pharmaceutical Manufacturing
Benefits
Medical insurance
Vision insurance
401(k)
Pension plan
Equal Employment Opportunity and Reasonable Accommodations MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.
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Base pay range:
$100,000.00/yr - $145,000.00/yr
Previous Pharmaceutical/Biotech experience is mandatory for this role.
This outstanding opportunity joins our growing team of engineers and specialists in project management, commissioning, and qualification. The successful candidate will work with a group of engineers and specialists involved in project management, commissioning, and qualification of equipment, systems, and facilities.
Responsibilities
Provide technical guidance for the commissioning, qualification, and startup of equipment and facilities used in life science manufacturing, such as bioreactors, tanks, CIP, buffers, media, chromatography, TFF, washers & autoclaves, etc.
Lead development of key qualification deliverables during the project lifecycle to ensure project scope is well defined and the action plan to test the system is appropriate.
Lead qualification processes throughout the project lifecycle such as VPP, Risk Assessments, RTM, DQ, FAT, SAT, IQ, OQ and PQ to ensure timely completion and compliance with quality and engineering specifications.
Experience with C&Q of process equipment, utilities, facilities is an asset. Thermal Validation experience is an asset.
Coordinate meetings with cross‑functional departments to drive project progress, facilitate decisions, and provide updates.
Engage other departments, as required, for design reviews and decisions.
Travel may be occasionally required for meetings with clients, equipment fabrication vendors or Factory Acceptance Testing (FATs).
Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning/validation phases.
Client‑management: maintain key client relationships to support business development and pursue new work, project scheduling/budgeting, coordination of client and MMR resources for effective delivery, and support business development through proposals and technical presentations at industry conferences.
Visit construction and installation sites following all site safety requirements.
Other duties as assigned by client, and/or MMR, based on workload and project requirements.
Qualifications
8–12+ years of experience in commissioning, qualification, or validation of various systems within the pharmaceutical/biotech industry.
Excellent written and spoken English, including preparation of technical documents in English.
Knowledge of cGMP operations, SOPs, Change Controls, Validation, and related regulatory requirements.
Experience with developing and executing validation projects, using risk‑based commissioning & qualification approaches such as ASTM E‑2500 or ISPE ICQ, is an asset.
Experience with commissioning and qualification of biotech process equipment (upstream or downstream, e.g., fermentation, bioreactors, chromatography, TFF, UF); required.
Experience with commissioning & qualification of process control systems (PCS, SCADA, historians) and building automation systems (Siemens Insight/Desigo, JCI Metasys) is an asset.
Experience with qualification or validation of clean utilities, ISO clean rooms, and thermal validation is an asset.
Experience preparing and executing URS’s, DQ’s, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, OQs, NCRs, and Final Reports.
Ability to lift 50 lbs.
Engineering or Science degree, preferably in Mechanical, Electrical, Chemical, Biochemical, Electromechanical or related discipline.
Ability to handle multiple projects and work in a fast‑paced environment.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Engineering, Manufacturing, and Consulting
Industries Pharmaceutical Manufacturing
Benefits
Medical insurance
Vision insurance
401(k)
Pension plan
Equal Employment Opportunity and Reasonable Accommodations MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.
#J-18808-Ljbffr