Sr. Engineer, Commissioning, Qualification and Validation

vor 2 Monaten

Visp, Schweiz Vaxcyte Vollzeit

Join our Mission to Protect Humankind

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.

WHAT we do is every bit as important as HOW we do it Our work together is guided by four enduring core values:

*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.

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

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

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

Summary:

As Vaxcyte’s products progress towards late stage and commercialization, Vaxcyte is implementing dedicated biologics manufacturing facilities. This position will support all aspects of CQV activities related to commercial Launch and routine GMP Manufacturing to ensure the efficient and compliant production of Vaxcyte's products.

Working closely with Process Development, MSAT, Supply Chain, Quality, Project Management, Business Development Regulatory functions and with CDMOs; the (Senior) CQV Engineer will be responsible for leading and oversight of commissioning, qualification, and validation activities for biologics manufacturing facilities, systems, and equipment. This role is critical in ensuring that all processes and systems meet regulatory and company standards. The successful candidate will collaborate with cross-functional teams to support new installations, upgrades, and ongoing operations. Cross-functional teamwork and successful working with CDMOs is key in this role. This position will report to the Director of Engineering of Vaxcyte Switzerland.

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 cGMP 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 DeltaV, 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 cGMP, 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.

Reports to: Vice President, Managing Director

Location: Visp, Switzerland

Compensation:

The compensation package will be competitive and includes an equity component.

Vaxcyte Switzerland GmbH

Rottenstrasse 5

3930 Visp, Valais

Switzerland

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

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