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, 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 process systems engineering activities related to commercial Launch, and routine GMP Manufacturing to ensure the efficient and compliant production of Vaxcyte's products.
The Staff Engineer, Process Systems will work closely with Process Development, MSAT, Supply Chain, Quality, Project Management, Business Development, and Regulatory functions, as well as CDMOs. This role is responsible for leading and overseeing process systems-related activities for biologics manufacturing facilities, systems, and equipment.
As a technical leader within the field, the Staff Engineer, Process Systems ensures that all processes and systems comply with regulatory and company standards, contributes to the development of company concepts & principles and solves complex problems in creative and effective ways. The role involves collaborating with cross-functional teams to support new installations, system upgrades, and ongoing operations. Effective cross-functional teamwork and successful engagement with CDMOs are critical to success in this position. This position will report to the Director of Engineering & Facilities at Vaxcyte.
Essential Functions:
Process System Owner:
- Lead and manage all engineering activities for advanced biotechnological systems, including utilities, process equipment, automation systems, and facilities.
- Work on significant and unique issues where analysis of situations or data requires an evaluation of intangible variables and may impact future concepts, products or technologies.
- Review and approve process equipment documentation, such as protocols, test plans, reports, and other deliverables, ensuring alignment with company standards and regulatory requirements.
- Conduct comprehensive risk assessments and design strategies to validate and optimize critical process parameters in compliance with industry standards and regulatory guidelines.
- Lead complex system and equipment inspections, including FATs (Factory Acceptance Tests), SATs (Site Acceptance Tests), and IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification), ensuring precision and compliance.
- Lead engineering feasibility studies, conceptual & basic design activities for projects across a range of products and sites.
Validation:
- Direct and manage validation initiatives, ensuring compliance with cGMP, FDA, EMA, and other applicable regulatory agencies.
- Oversee the review and approval of validation protocols, plans, and reports, ensuring their alignment with industry standards and ensuring robust and reliable processes.
- Analyze complex validation data to identify critical trends, continuously improving the reliability, efficiency, and compliance of validated systems.
Project Management:
- Create formal networks with key decision makers and serves as an external spokesperson for the organization with CDMO and supplier partners.
- Oversees the activities of a project and teams involved in cross-functional engineering projects from conception through completion, balancing complex timelines, budget constraints, resource allocation, and quality standards.
- Collaborate effectively with senior project managers, cross-functional teams, contractors, and external vendors to coordinate, prioritize, and execute engineering activities.
- Provide strategic technical leadership and fostering a culture of innovation, collaboration, and continuous improvement.
- Ensure project deliverables are met within scope and timeline while maintaining focus on compliance, quality, and cost-effectiveness.
Regulatory Compliance:
- Ensure full regulatory compliance of all systems with FDA, EMA, and other global regulatory requirements.
- Lead and support regulatory inspections, audits, and customer site visits, including presenting documentation and addressing regulatory concerns with senior leadership.
- Monitor, interpret, and incorporate changes in regulatory guidelines, ensuring Vaxcyte's engineering processes are continuously aligned with evolving standards.
Leadership and Strategy:
- Exercise latitude in determining objectives and approaches to critical assignments.
- Manage technical and budgetary responsibilities and the day-to-day activities of other engineers.
- Establish oneself as a strategic leader within the organization regarding critical technologies, their implementation and continuous improvement.
- Drive strategic improvements in engineering processes, tools, and methodologies, ensuring the continuous optimization of systems and compliance practices across the organization.
- Act as a key leader in the development and mentoring of the engineering team, fostering professional growth and technical excellence.
- Collaborate with senior leadership to define long-term engineering strategies and goals, ensuring alignment with organizational objectives and growth plans.
- Lead the transition from capital project implementation to ongoing engineering support for commercial manufacturing, emphasizing preventive maintenance, continuous improvement, equipment upgrades, and the integration of evolving industry standards to ensure operational efficiency and compliance.
- Take accountability (budgetary, timeline and meeting success criteria) for complex projects, scopes of work and technical troubleshooting.
- Drive strategic alignment, standardization and adoption of engineering lifecycle management programs with CDMOs and partners.
Requirements:
Bachelor's or Master's degree in Engineering (Chemical, Mechanical, Biomedical, or related field) or Biotechnology with a minimum of 10+ years of experience in Bioprocessing/Process Engineering within the biotechnology, pharmaceutical, or biopharmaceutical industry. Other combinations of education and/or experience may be considered.
- Proven leadership experience in managing teams and large-scale Capex projects, including utilities, process equipment, and automation systems.
- Extensive knowledge of biopharmaceutical manufacturing processes and equipment, particularly DCS, ISA-88 batch process control, and PLC-based control systems.
- Demonstrated success in managing engineering activities for large-scale or complex facilities under tight timelines and budget constraints.
- Expertise in drug product manufacturing and associated unit operations including compounding, automated visual inspection, assembly, labelling & packaging.
- Expert-level knowledge of cGMP, FDA, EMA, ICH guidelines, and other global regulatory requirements.
- Strong understanding of bioprocessing, including upstream and downstream processing, aseptic processing, and sterilization techniques.
- Advanced proficiency in statistical analysis, risk assessment methodologies, and process validation best practices.
- In-depth experience with quality management systems (QMS) and electronic documentation systems to maintain compliant documentation and support audit activities.
- Capability to support and, when required, perform a range of broader engineering functions and activities, including project management, process optimization, automation, and utilities engineering.
- Exceptional leadership, communication, and interpersonal skills, with the ability to influence at all levels of the organization and external partners.
- Strong problem-solving, analytical thinking, and decision-making capabilities, especially in high-pressure environments.
- Ability to prioritize and manage multiple complex projects, balancing conflicting demands while ensuring regulatory compliance and business goals.
- Excellent mentoring and coaching abilities, fostering a culture of innovation and continuous improvement.
Reports to: Sr. Director, Engineering & Facilities
Location: North Carolina
Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): Remote
Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $157,000 – $183,000
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.
