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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.

Commissioning and Qualification:

• Supervise commissioning and qualification activities for new and existing biotechnological systems, including utilities, equipment, and automation systems.
• Review commissioning and qualification documentation (e.g., protocols, test plans, reports).
• Perform risk assessments, identify critical process parameters, and ensure compliance with regulatory requirements.
• Conduct system and equipment inspections, FATs (Factory Acceptance Tests), SATs (Site Acceptance Tests), and IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification) activities.

Validation:

• Oversee and perform process, cleaning, and computer system validation (CSV) activities.
• Review validation protocols, plans, and reports, ensuring alignment with c GMP and industry standards.
• Analyze validation data, identify trends, and ensure the reliability and robustness of validated processes.

Project Management:

• Lead CQV projects from inception through to completion, ensuring project timelines, budgets, and quality standards are met.
• Collaborate with project managers, contractors, and other stakeholders to coordinate and execute CQV activities effectively.
• Provide technical expertise and guidance to junior engineers, contractors, and other team members.

Regulatory Compliance:

• Ensure all CQV activities are compliant with FDA, EMA, and other relevant regulatory agencies' requirements.
• Prepare for and support regulatory inspections, audits, and customer site visits, including the presentation of CQV documentation and activities.
• Stay up-to-date with regulatory changes and industry best practices, incorporating them into CQV processes.

Requirements:

• Bachelor’s or Master’s degree in Engineering (Chemical, Mechanical, Biomedical, or related field) or Biotechnology.
• Minimum of 7 years of experience in CQV within the biotechnology or pharmaceutical industry.
• Extensive experience with biopharmaceutical manufacturing processes and equipment.
• Experience with Delta V, Syncade MES, and PLC based process control.
• Proven track record in leading CQV projects, including utilities, process equipment, and automated systems.
• In-depth knowledge of c GMP, FDA, EMA, ICH guidelines, and other relevant regulatory requirements.
• Strong understanding of bioprocessing, including upstream and downstream processing, aseptic processing, and sterilization techniques.
• Proficient in statistical analysis and risk assessment methodologies.
• Familiarity with quality management systems (QMS) and electronic documentation systems.
• Excellent problem-solving and analytical skills.
• Strong leadership and team collaboration abilities.
• Effective communication skills, both written and verbal.
• Ability to manage multiple projects and priorities in a fast-paced environment.
• Previous experience interacting with CMOs and Vendors to meet project deadlines.