Pharmaceutical - Commissioning & Qualification (C&Q) Validation Manager

Company: MMR Consulting
Location: Carlsbad
Posted on: June 1, 2025

Job Description:

Previous pharmaceutical/biotech experience is mandatory for this role.MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and other Consulting services. MMR's expertise encompasses Process, Automation, and Facilities engineering. Our pharmaceutical expertise includes Oral Solid Dosage, Semi-Solids, Liquid-Dosage (TS and Aseptic), API manufacturing, and Biotechnology (Vaccines, Blood Plasma Fractions, Monoclonal Antibodies).MMR Consulting has offices in Canada, USA, and Australia.This is an outstanding opportunity to join our growing team, where the successful candidate will work with engineers and specialists involved in project management, commissioning, and qualification of equipment, systems, and facilities. The work will require working at the client's facilities. This role is for our client in San Diego.The ideal candidate should possess leadership skills to lead and mentor intermediate/junior engineers.Responsibilities

• Manage and lead a team of CQV engineers and specialists.
• Provide technical guidance for commissioning, qualification, and start-up of pharmaceutical/biopharmaceutical cGMP process equipment, utilities, and facilities.
• Lead development of key qualification deliverables such as DQ, FAT, SAT, IQ, OQ, and PQ during the project lifecycle.
• Perform field execution of qualification test cases and protocols.
• Support the development of Project Validation Plans (PVPs) to ensure testing actions are applicable and relevant.
• Lead qualification processes throughout the project lifecycle to ensure timely completion and adherence to quality and engineering specifications.
• Possess knowledge of regulatory requirements and industry best practices related to process equipment, utilities, automation systems, laboratory equipment, and facilities.
• Coordinate meetings with cross-functional departments to drive project progress, facilitate decisions, and provide updates.
• Engage other departments in design reviews and decisions as required.
• Occasionally travel for meetings with equipment vendors or Factory Acceptance Tests (FATs).
• Support shutdowns or extended hours during installation, construction, commissioning, qualification, and validation phases.
• Visit construction and installation sites, wearing necessary safety PPE.
• Participate in client management, project scheduling, budgeting, resource coordination, business development, and industry conference presentations or publications.
• Supervise contractors during critical testing of systems and equipment.
• Perform other duties as assigned by the client or MMR based on workload and project needs.
• Comply with client safety rules, including vaccination policies for COVID-19 where applicable.Qualifications
• 8+ years of experience in commissioning, qualification, or validation within the pharmaceutical/biotech industry.
• Some leadership experience is required.
• Experience with commissioning and qualification of equipment and facilities is required.
• Validation experience such as cleaning validation, thermal validation, mixing studies, process validation, and computer systems validation is an asset but not required.
• Previous experience in the industry with knowledge of cGMP requirements is essential.
• Experience with risk-based validation approaches like ASTM E-2500 or ISPE ICQ is an asset but not required.
• Experience with process control systems (PCS, SCADA, Historians) and building automation systems is an asset.
• Experience with biotech process equipment such as fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF) is an asset.
• Experience with qualification or validation of clean utilities and ISO cleanrooms.
• Experience with preparation and execution of URS, DQ, RTMs, risk assessments, CPPs, VPPs, FATs, SATs, IOQs.
• Leadership skills to manage validation staff, prioritize tasks, provide mentorship, and resolve issues. Leadership experience is an asset but not required.
• Possess leadership and initiative to lead projects involving multiple stakeholders and departments.
• Mentorship skills to coach and develop junior and intermediate staff.
• Engineering degree, preferably in Mechanical, Electrical, or Chemical engineering.
• Ability to travel occasionally.
• Ability to handle multiple projects and work in a fast-paced environment.
• Strong multi-tasking skills.Compensation range: $70,000 - $120,000 based on experienceEqual Employment Opportunity and Reasonable AccommodationsMMR 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 you need a reasonable accommodation during the application or interview process, please inform us of your request.
  #J-18808-Ljbffr

Keywords: MMR Consulting, Rancho Cucamonga , Pharmaceutical - Commissioning & Qualification (C&Q) Validation Manager, Healthcare , Carlsbad, California