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1 день назад

Sr Associate Technical Engineer (Pharmaceutical Manufacturing)

82 700 - 137 900$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Sr Associate Technical Engineer (Pharmaceutical Manufacturing): Developing and executing cleaning validation, clean utility equipment qualification, and validation deliverables for Pfizer's Pearl River manufacturing site with an accent on cGMP compliance, equipment projects, and cross-functional coordination. Focus on authoring validation plans and technical reports, managing project milestones and vendors, and supporting audits and clean-room manufacturing operations.

Location: On premise in Pearl River, New York, United States; candidates must have permanent U.S. work authorization. The role requires approximately 25% shop-floor presence, clean-room gowning, occasional evening or weekend work, and the ability to work with cytotoxic materials, pressurized systems, steam, and corrosive chemicals.

Annual base salary: $82,700–$137,900, plus eligibility for a 10% bonus target.

Company

hirify.global is a pharmaceutical and biotechnology company; this role supports manufacturing, clean utilities, equipment cleaning, and validation programs at the Pearl River site.

What you will do

  • Develop and execute cleaning validation and clean utility equipment qualification protocols and reports.
  • Author, review, and approve technical reports, development studies, periodic reviews, validation plans, risk assessments, validation strategies, SOPs, and job aids.
  • Manage milestones for new processes, technology transfers, and equipment installations with Operations, Opex, and Engineering.
  • Coordinate vendor and contractor resources and matrix deliverables with project teams of up to 10–15 colleagues.
  • Participate in operational and shift huddles and support regulatory and internal audits, including response coordination.

Requirements

  • Associate degree with 5+ years of relevant experience, BA/BS with 2+ years of relevant experience, or MBA/MS with any amount of relevant experience.
  • Experience in pharmaceutical or biotechnology manufacturing and associated clean utilities or CIP systems.
  • Knowledge and experience with cGMP and FDA rules and regulations.
  • Proficiency in data analysis and trend monitoring.
  • Strong ownership, accountability, organization, time management, collaboration, and communication skills, including explaining issues and solutions to PCT and senior management.
  • Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, with understanding of responsible AI practices, risk management, and ethical use.
  • Ability to lift approximately 50 pounds, stand or walk for extended periods, use stairs, and perform hands-on mechanical work safely in manufacturing and clean-room environments.
  • Must be authorized to work in the United States by any employer and hold permanent U.S. work authorization.

Culture & Benefits

  • Full-time, on-premise position with matrix collaboration across Operations, Technical Services, Engineering, Supply Chain, QC, QA, EHS, Maintenance, Automation, and Digital functions.
  • Occasional off-hours work may be required, including evenings and weekends, with aseptic and personnel-safety gowning requirements.
  • Benefits include a 401(k) with hirify.global matching and additional retirement contributions, paid vacation and holidays, personal days, caregiver/parental and medical leave, and medical, prescription, dental, and vision coverage.
  • Relocation assistance may be available based on business needs and eligibility.
  • U.S. work visa sponsorship, including TN, O-1, and H-1B sponsorship, is not available now or in the future.

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