Senior Manager, CQV

The Sr. Manager CQV Engineer position is responsible for developing and executing the commissioning, qualification, and validation of our new state-of-the-art Cell & Gene Therapy Manufacturing facility to be located in Pittsburgh, PA. The Sr. Manager CQV will provide technical and validation support for capital projects and facilities and manufacturing operations (assets lifecycle) working with facilities & engineering, manufacturing, MSAT, Quality Control and Quality Assurance (QA) teams.

Here's What You'll Do

• Ensure preparation, development, review of high-level CQV documentation such as Site Validation Master Plan (SMVP), Project Commissioning / Validation Plans, risk assessments, system/component level Impact Assessments, criticality assessments, Quality Plans, traceability matrices, etc. Ensure adherence to a commissioning and qualification schedule and Validation Project plan for the facility, utilities, process, and analytical equipment.
• Review and approval of commissioning and qualification protocols and reports for facility, utilities, IT-OT, process, and analytical systems and equipment.
• Review and approval of change controls to release facilities, utilities, process, and analytical equipment for GMP manufacturing use.
• Lead validation activities and deliverables to meet the overall facility and operations milestones.
• Oversee external contractors and vendors during commissioning and qualification activities.
• Prepare, review, and support asset documentation lifecycle (risk assessments, URS, FAT/SAT, IOQ, Commissioning, SOPs, etc.), to support new or existing facilities, utilities, and equipment.
• Ensure tasks and deliverables are executed and accomplished per ElevateBio Project/Validation Master Plan and other required Policies and Procedures.
• Ensure preparation of testing templates and qualification protocols using paper and electronic validation systems (e.g. Kneat )
• Maintain the Site Validation Master Plan, engineering lifecycle documents, and Validation Program SOPs.
• Ensure safety is integrated into the design and CQV execution of all projects and activities (reviews with EHS representatives).
• Prepare/review automation sequences, as required for Process Automation / OT systems.
• Engage and coordinate CQV activities with other engineering disciplines and other cross-functional departments (process, IT-OT, facilities, procurement, construction management, manufacturing operations, EHS, quality & compliance).
• Support site capital projects (improvements, modifications, expansions, etc.) projects as well as regular operations (CQV activities for new or existing assets - periodic reviews, modifications, replacements, etc. of equipment, utilities, and facilities systems)
• Promote and ensure adequate application of CQV & engineering best practices, Policies and SOPs, and cGMP regulations throughout assets and systems lifecycle.
• Support and execute quality compliance systems (e.g. Change Controls, Deviations, CAPAs, etc.) to qualified facilities, equipment, and utilities.

Requirements

• Experience in engineering / project management of FDA regulated manufacturing facility, preferably biopharmaceuticals / aseptic / ATMP operations.
• Bachelor's degree in engineering, or a related discipline and experience.
• Experience in cGMP facility/equipment start-up, commissioning, and qualification.
• Experience in cGMP processes such upstream cell expansion, downstream purification, and fill finish. Viral vector & ATMP / C> (allogeneic and autologous) commercial manufacturing experience is a plus.
• Experience using validations tools such as KNEAT is preferred.
• Strong understanding of ASTM E2500 standards for commissioning, validation, and lifecycle management of GMP utilities, equipment, systems, and QC laboratories
• Strong interpersonal communication skills and ability to work effectively with internal cross functional teams, vendors, and contract resources.
• 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.
• Proficient at applying good engineering practices, industry guidance (ISPE, ISO, GAMP) and regulatory requirements (EU, UK, JP, 21 CFR 210, 211, 620, Part 11, ICH, WHO, etc.)
• Required experience with good documentation practices, technical writing, and cGMP standards.
• Ability to manage priorities, deliverables, and schedule milestones.
• Proficiency with Procore, Smartsheet, Microsoft Project, Bluebeam Revu is a plus.

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