Elektrofi · 1 day ago
Associate Director, Process Engineering
Boston, MA
Full-time
Onsite
Lead/Staff, Director/Executive
$165K/yr - $190K/yr
10+ years expHalozyme Hypercon is a subsidiary of Halozyme Therapeutics, Inc. focused on innovating drug delivery solutions. The Associate Director, Process Engineering will lead engineering initiatives, manage equipment design and facility readiness, and collaborate with cross-functional teams to ensure compliance and operational efficiency.
BiotechnologyWellnessAlternative MedicineTherapeutics
Responsibilities
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
Qualification
Required
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 equipment suppliers through design and CQV project phases
In-depth understanding of GMPs, FDA/EMA expectations, ISPE baseline guides, and ASTM E2500 principles
Experience supporting aseptic formulation and filling operations, or related drug substance manufacturing platforms
Strong project management and cross-functional leadership skills with the ability to influence without authority
Excellent technical writing and communication skills, with the ability to prepare and present complex information clearly to senior stakeholders
Ability to thrive in a matrixed, fast-paced, and evolving environment with shifting priorities
Willingness to travel domestically and internationally (~25–40%) during major start-up and qualification phases
Benefits
Employee Stock Purchase Program
401(k) matching
Opportunities to grow in a culture that prioritizes learning, development and progression through in-house programs and tuition reimbursement
Company
Elektrofi
Elektrofi develops hyper concentration microparticle technology for subcutaneous biologic medicine delivery.
51-200 employees
H1B Sponsorship
Elektrofi has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (1)
2023 (2)
2022 (2)
2020 (2)
Funding
Current Stage
Growth StageTotal Funding
$154.11MKey Investors
Novo Holdings,RA Capital Management,Royalty PharmaBiotechnology Value Fund,Marshall WaceNational Science Foundation
2025-10-01Acquired
2024-08-22Series C· $112.25M
2022-06-13Series B· $40M
Leadership Team
Victoria Sluzky
Chief Technology Officer
Recent News
The Motley Fool
2026-01-24
GlobeNewswire
2026-01-12
The Motley Fool
2025-12-06
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