Lead Validation Specialist

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 Validation. This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers and specialists involved in the engineering and project management of equipment, systems and facilities for life sciences facilities. This role is for a LEAD Validation Engineer / Specialist to work on the Validation startup of process systems/equipment in the biopharmaceutical industry, as well as process equipment in pharma/biotech industries. The ideal candidate should possess leadership skills to lead/mentor junior engineers.

Lead the development of validation strategies or deliverables such as protocols, reports, deviation resolution process and training during the project validation lifecycle.
• Able to perform field execution of validation 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 such as DQ, FAT, SAT, IQ, OQ and PQ as appropriate to ensure timely completion and to ensure all quality and regulatory specifications are met.
• Provide technical guidance into the Process Validation (PV) and / or Cleaning Validation (CV) aspects of Manufacturing Science and Technical Operations (MSAT) in the pharmaceutical / biopharmaceutical cGMP manufacturing or R&D operations.
• Serve as Validation SME, coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates for execution of validation activities.
• Travel may be occasionally required for meetings with equipment fabrication vendors or Factory Acceptance Testing (FATs).
• 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.

8+ years for years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry.
• Knowledge of requirements for a cGMP operations, including SOPs, Change Controls, Validation.
• Experience with developing and executing validation projects. Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset, but not required.
• 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.
• Thermal validation experience is considered an asset.
• Experience with commissioning and qualification of process equipment for aseptic fill-finish and pharmaceutical API and OSD manufacturing processes are considered an asset.
• Experience with qualification or validation of clean utilities and HVAC/ISO clean rooms.
• Experience with preparation and execution of URS's, DQ's, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, Final Reports.
• Possess knowledge of relevant regulatory requirements and industry best practices on assessing / implementing all or any of the following -
• PV - Process variation sources, presence detection and degree, impact and controls, DoE, PPQ, gap analysis, process design, process qualifications & continued process verification
• CV - Cleaning & Sanitization, Holding times (DEHT / CEHT), Cycle times, FIP/CIP/SIP, CCP, MAR, wetted/non-wetted product contact areas, sampling methods and analysis
• Lead teams of Validation staff, manage staff priorities, provide mentorship/oversight, help staff resolve issues. 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 or Science degree, preferably in Mechanical, Electrical, Chemical, Biochemical, Electromechanical or a related discipline.
• Ability to handle multiple projects and work in a fast-paced environment.
• We celebrate diversity and are committed to creating an inclusive environment for all employees. 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.

Artificial intelligence (AI) is used during the screening of applications.