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  RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.

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  AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.

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  LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.

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  MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

Essential Functions:

• Collaborates closely with Senior Management, Functional/Department Heads, and project team members.
• Makes sure that accurate and up-to-date records of manufacturing processes, quality control testing, and regulatory compliance activities are available.
• Ensures compliance with regulatory requirements, including GMP, safety and environmental regulations, and other relevant guidelines.
• Supports validation and qualification activities for equipment, processes, and facilities to ensure compliance with regulatory requirements and industry standards.
• Improve productivity and for continuous process improvements
• 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.
• Oversee 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 Project/Validation Master Plan and other required Policies and Procedures.
• Ensure discrepancies are resolved and closed out in a timely manner.
• Ensure preparation of testing templates and qualification protocols using paper and electronic validation systems (e.g. Kneat ™).
• 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 and e MBR.
• Prepare/review automation sequences, as required for Process Automation / OT systems and e MBR.
• 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, according to Vaxcyte’s Policies and SOPs, and c GMP regulations throughout assets and systems lifecycle.
• Ensure all validation activities are in compliance with site, authorities having jurisdiction (Swissmedic, FDA, EMA, etc.) regulatory requirements.
• Support and execute quality compliance systems (e.g. Change Controls, Deviations, CAPAs, etc.) to qualified facilities, equipment, and utilities.

Requirements:

• 10+ years of experience in engineering / project management of Swissmedic, FDA, EMA regulated manufacturing facility, preferably biopharmaceuticals / aseptic / small molecules API operations.
• Bachelor’s degree in engineering, or a related discipline and experience.
• Experience in c GMP facility/equipment start-up, commissioning, and qualification.
• Experience in c GMP processes such upstream cell expansion, downstream purification, and fill finish.
• Experience using validations tools such as KNEAT ™ is preferred.
• Strong understanding of current Gx P 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 (PIC/S, EU, UK, JP, 21 CFR 210, 211, 620, Part 11, ICH, WHO, etc.).
• Required experience with good documentation practices, technical writing, and c GMP standards.
• Ability to manage priorities, deliverables, and schedule milestones.