Director, Engineering and Facilities
Vaxcyte
Operations
3930 Visp, Switzerland
Posted on Tuesday, March 19, 2024
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:
*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.
*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.
*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 initiating development of dedicated biologics manufacturing facilities. This position will be responsible to support all aspects of strategic and operational activities related to GMP Manufacturing Engineering and Facilities. The strategic activities will include development of manufacturing network strategy, site selection process, facility due-diligence, regulatory and governmental interfaces, and facility acquisition. From an operational standpoint, this position will lead Vaxcyte’s Manufacturing Engineering and Facilities management including design, construction, startup, validation, and licensing. This position will be responsible for overseeing a portfolio of capital projects around the world.
Working closely with Process Development, Quality, Manufacturing, and Regulatory functions; this position will oversee facility build/upgrade projects and drive implementation of the global manufacturing network strategy. This role will be critical to timely, compliant, secure, and uninterrupted supply of Vaxcyte’s innovative therapies. It is necessary to possess solid knowledge of GxP (GMP, GLP, GCP) regulations. Solid expertise in global engineering and facilities, cross-functional teamwork, and building successful organizations is paramount in this role. This position will report to the Executive Director Operations of Vaxcyte Switzerland.
Essential Functions:
- Provide leadership, strategic direction, risk assessment and oversight for translation of the corporate strategy into supportive strategies for Engineering.
- Represent the company on critical and confidential projects and provide recommendations.
- Develop and maintain site master plans and oversee facility expansion and modification projects including planning, design, construction, qualification, and operational readiness.
- Lead the internal project team for design, construction and CQV of new facilities.
- Responsible for various sub functions within Engineering & Facilities, area including Maintenance, Engineering, Calibration, Automation, Equipment Validation, Site Services, and EHS; to allow Vaxcyte to grow and become a leader in bacterial vaccines.
- Create and monitor key performance indicators, highlighting progress, risks, and mitigation options.
- Collaborate closely with Senior management, Functional/Department Heads, and project team members as well as with involved CDMOs and Engineering Companies
- Coordinate resource planning across programs to ensure adequate resources are available, escalate and resolve issues.
- Proactively identify and quickly resolve issues and problems.
Requirements:
- Bachelors' Degree in Engineering, MS Degree in Engineering or MBA preferred.
- 10+ years of professional management experience in leading Capex projects for GMP plants in the field of Biopharma.
- Knowhow in equipment and utilities engineering as well as CQV activities.
- Proven experience in managing engineering of Large Molecule GMP manufacturing facilities, microbial manufacturing experience desirable.
- Demonstrated ability to work effectively at all levels of an organization.
- Successful facility start-up and commercialization experience from an Engineering perspective.
- Strong organizational, management, teamwork, interpersonal skills, and professionalism required.
- Proven leadership for the creation of a robust, scalable, and compliant manufacturing facility, processes, and systems.
- Proven leadership in the development and mentoring of staff.
- Experience working with CDMOs: overseeing and stirring all aspects of Capex projects at CDMO by building solid relationships with Vaxcyte’s partner.
- Demonstrated experience in establishing Quality and Safety mindset/behaviors and a culture of continuous improvement.
- Relentless focus and passion around process improvements (efficiency and automation).
- Financial acumen, experience in creating, managing, and adhering to budgets.
- Ability to balance, prioritize, and resolve conflicts.
- Manage multiple projects in a fast-paced environment.
Reports to: Vice President, Managing Director
Location: Visp, Switzerland
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Send resumes to:
Vaxcyte, Inc.
825 Industrial Road, Suite 300
San Carlos, CA 94070
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.