Sr Associate Technical Engineer (Pharmaceutical Manufacturing)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
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
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 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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