MMR Consulting · 11 hours ago
BIOPHARMACEUTICAL – C&Q ENGINEER
Vacaville, CA
Full-time
Onsite
Mid, Senior Level
$80K/yr - $120K/yr
3+ years expMMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. They are seeking a Biopharmaceutical C&Q Engineer to work on the commissioning, qualification, and startup of bioprocess systems and equipment in the biopharmaceutical industry.
BiotechnologyIndustrial AutomationLife ScienceManagement Consulting
Responsibilities
Provide technical guidance into the commissioning, qualification and start-up of various equipment and facilities used in life science manufacturing, such as bioreactors, tanks, CIP, Buffers, Media, Chrom, TFF, washers & autoclaves, etc
Lead the development of key qualification deliverables during the project lifecycle to ensure project is well defined, and the action plan to test the system is applicable and relevant
Lead qualification processes throughout the project lifecycle such as VPP, Risk Assessments, RTM, DQ, FAT, SAT, IQ, OQ and PQ as appropriate to ensure timely completion and to ensure all quality and engineering specifications are met
Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports
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, 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 in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc
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
Qualification
Required
Previous Pharmaceutical/Biotech experience is mandatory for this role
3-6+ years for years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry
Engineering or Science degree, preferably in Mechanical, Electrical, Chemical, Biochemical, Electromechanical or a related discipline
Excellent written and spoken English is required including the preparation of technical documents in English
Knowledge of requirements for a cGMP operations, including SOPs, Change Controls, Validation
Ability to lift 50 lbs
Ability to handle multiple projects and work in a fast-paced environment
Strong multi-tasking skills
Preferred
Experience with developing and executing validation projects
Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset
Experience with commissioning and qualification of biotech process equipment (upstream or downstream or both), such as some, but not all, of the following: fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF) is required
Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems (i.e. Siemens Insight / Desigo, JCI Metasys) are considered an asset
Experience with Qualification or Validation of clean utilities, ISO clean rooms, and Thermal Validation is considered an asset
Experience with preparation and execution of URS's, DQ's, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, Final Reports
Company
MMR Consulting
MMR Consulting specializes in process automation and capital project management of complex projects for biotechnology industries.
51-200 employees
H1B Sponsorship
MMR Consulting has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
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Trends of Total Sponsorships
2025 (6)
2024 (1)
2023 (3)
2022 (5)
2021 (4)
2020 (1)
Funding
Current Stage
Growth StageLeadership Team
Michael Rodionov
Founder, President & Principal
Recent News
2024-04-08
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