MMR Consulting · 1 day ago
Biopharmaceutical SR. COMMISSIONING & QUALIFICATION SPECIALIST
Raleigh, NC, US
Full-time
Onsite
Senior Level, Lead/Staff
$90K/yr - $115K/yr
12+ years expMMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. They are seeking a Senior Commissioning & Qualification Specialist to provide technical guidance on commissioning, qualification, and start-up of various pharmaceutical and biopharmaceutical cGMP process equipment, utilities, and facilities.
BiotechnologyIndustrial AutomationLife ScienceManagement Consulting
Responsibilities
Provide technical guidance into the commissioning, qualification and start-up of various pharmaceutical / biopharmaceutical cGMP process equipment, utilities & facilities
Lead the development (for example, write test cases) 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 specifications are met
Possess knowledge of relevant regulatory requirements and industry best practices on all or any of the following
Process equipment, clean utilities, automation systems, laboratory equipment, building & facilities
Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates
Engage other departments, as required, into design reviews and decisions
Travel may be occasionally required for meetings with equipment fabrication vendors or Factory Acceptance Testing (FATs)
Work may require occasional support over shutdowns or extended hours, specifically during installation, construction, commissioning, qualification and validation phases
Visit construction and installation sites, wearing necessary safety PPE
You may be involved with other aspects such as 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
Supervise contractors during critical testing of system and equipment
Other duties as assigned by client, and/or MMR, based on workload and project requirements
Lead/Mentor a team of validation specialists
Qualification
Required
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
Possess knowledge of relevant regulatory requirements and industry best practices on all or any of the following: Process equipment, clean utilities, automation systems, laboratory equipment, building & facilities
Ability to handle multiple projects and work in a fast-paced environment
Strong multi-tasking skills
Ability to lift 50 lbs
Preferred
Validation experience such as cleaning validation, thermal validation, mixing studies, process validation, computer systems validation is an asset but not required
Experience with developing and executing validation projects to Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ
Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems are considered an asset
Experience with commissioning and qualification of biotech process equipment, such as some, but not all, of the following: fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF), CIP systems, Buffer systems, Clean Utilities would be an asset
Experience with Qualification or Validation of clean utilities and ISO clean rooms
Experience with preparation and execution of URSs, DQs, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs
Leadership is considered an asset, but not required
Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity
Possess mentorship skills, to coach and develop junior and intermediate employees
Engineering degree, preferably in Mechanical, Electrical or Chemical
Travel may be required on occasion
Travel may be occasionally required for meetings with equipment fabrication vendors or Factory Acceptance Testing (FATs)
Work may require occasional support over shutdowns or extended hours, specifically during installation, construction, commissioning, qualification and validation phases
Benefits
Equal Employment Opportunity and Reasonable Accommodations
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)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
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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