Associate Director, Process Engineering
Listed on 2026-02-24
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Engineering
Process Engineer, Manufacturing Engineer, Validation Engineer, Biomedical Engineer
Description
Welcome to an inspired career.
At Halozyme Hypercon™, a wholly‑owned subsidiary of Halozyme Therapeutics, Inc., we are reinventing the patient experience and building the future of drug delivery. We are passionate about the important work we do and constantly strive to do more. We embrace transformation and work hard to innovate for the future. We do this together, as One Team – we rise by lifting others up and believe in the power of working together for the collective win.
That’s why we need you—to help us make a significant impact by taking on increasingly complex challenges, leaping beyond the status quo, advancing our mission and making our One Team culture thrive.
Join us as a Associate Director, Process Engineering, and you’ll be part of a culture that welcomes diversity, thinks differently to solve problems, works collaboratively as one team, and delivers meaningful innovations that impact people’s lives.
How you will make an impact
Halozyme Hypercon is seeking a highly motivated and experienced Associate Director, Process Engineering to lead the engineering, equipment, and facility readiness initiatives for our proprietary Hypercon™ formulation technology. This role will report to the Sr. Director, Head of Manufacturing Science & Technology and will focus on equipment design, facility start‑up, commissioning, qualification, and validation (CQV) activities in support of new manufacturing capabilities at internal and external sites.
The Associate Director will play a critical role in shaping Halozyme Hypercon's technical operations network by managing the design and deployment of robust, scalable, and compliant systems that enable successful clinical and commercial manufacturing. This individual will partner closely with Process Development, Engineering, Quality, Program Management, and CDMO partners to ensure new facilities and equipment are designed and qualified to meet current and future business needs.
this role, you’ll have the opportunity to:
- Perform all duties in accordance with Halozyme Hypercon's core values, policies, and cGMP regulations.
- Lead equipment design, procurement, installation, commissioning, and qualification for new Hypercon™ formulation suites and associated support systems.
- Serve as technical lead and owner for MSAT engineering projects including new facility design, utilities, automation, and process equipment integration.
- Partner with Engineering and Quality functions to develop and execute commissioning and qualification (CQV) master plans, FAT/SAT protocols, and IOQ documentation.
- Manage external engineering firms, equipment vendors, and system integrators to deliver projects on time, within budget, and in compliance with regulatory expectations.
- Provide technical expertise in process equipment specification, layout optimization, material flow, and contamination control strategies for aseptic formulation and filling operations.
- Collaborate with Process Development and Engineering teams to ensure seamless tech transfer from lab to manufacturing scale, ensuring process and equipment compatibility.
- Author, review, and approve technical documents including URSs, validation protocols, deviation reports, and risk assessments.
- Support readiness for facility start‑up and regulatory inspections by ensuring technical documentation and equipment qualification packages are complete and compliant.
- Apply Lean Six Sigma and risk‑based methodologies to optimize equipment performance, reduce downtime, and improve system reliability.
- Act as a key MSAT representative in cross‑functional project teams, supporting Halozyme Hypercon's strategic growth and manufacturing network expansion.
- B.S. or M.S. in Engineering (Mechanical, Chemical, or related field required; advanced degree preferred).
- 10+ years of experience in the biopharmaceutical or biologics industry, with at least 5 years in MSAT, Engineering, or Technical Operations supporting GMP manufacturing.
- Proven track record in equipment and facility design, start‑up, commissioning, and validation for biopharmaceutical manufacturing environments.
- Demonstrated experience managing CDMOs, engineering firms, and…
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