Associate Director, Process Engineering - Boston - Elektrofi

    Elektrofi
    Elektrofi Boston

    1 day ago

    $135,000 - $210,000 (USD) per year *
    Description

    Job Type
    Full-time
    Description
    Welcome to an inspired career.
    At Halozyme HyperconTM, 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 HyperconTM 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.
    In 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 HyperconTM 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.
    Requirements
    To succeed in this role, you'll need:
    • 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.
    In return, we offer you:
    • Full and comprehensive benefit program, including an Employee Stock Purchase Program and 401(k) matching.
    • Opportunities to grow in a culture that prioritizes learning, development and progression through in-house programs and tuition reimbursement.
    • A collaborative, innovative team that works as one to amplify your impact-on your career, the work you do and patients' lives.
    The most likely base pay range for this position is $165,000-$190,000 per year. Several factors, such as experience, tenure, skills, and particular business needs, will determine an individual's exact level of compensation. Base salary is only one element of employee compensation at Halozyme. Total compensation could include bonuses, sales incentives, and equity awards.
    Equal Employment Opportunity Statement
    Halozyme Hypercon, Inc is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race (including traits historically associated with race, including but not limited to: hair texture and protective hair styles), religion, religious creed (including religious dress and grooming practices), ethnicity, color, national origin, ancestry, age (40 and older), genetic information, disability (mental and physical, including HIV and AIDS), reproductive health decision-making, medical leave or other types of protected leave, domestic violence victim status, political affiliation, medical condition (including cancer/ genetic characteristics and information), sex, gender, gender identity, gender expression, sexual orientation, marital or familial status, citizenship, pregnancy (including perceived pregnancy, childbirth, breastfeeding, or related medical conditions), military or veteran status, or any other status protected by federal, state, or local law.
    Click here to view the Know Your Rights Poster.
    Accessibility and Reasonable Accommodations
    Halozyme Hypercon is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans during our application process. If you need assistance or an accommodation due to a disability, contact Human Resources at
    Halozyme Privacy Notice: Applicant Privacy Notice.
    To all agencies, please, no phone calls or emails to any employee of Halozyme Hypercon about this requisition. All resumes submitted by search firms/employment agencies to any employee at Halozyme Hypercon via email, the internet, or in any form and method will be deemed the sole property of Halozyme Hypercon unless such search firms/employment agencies were engaged by Halozyme Hypercon for this requisition and a valid agreement with Halozyme Hypercon is in place. If a candidate submitted outside of the Halozyme Hypercon agency engagement process is hired, no fee or payment of any kind will be paid.
    # LI-Onsite
    Salary Description
    * This salary range is an estimation made by beBee
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