200510503Z Thermo Fisher Scientific Pte. Ltd. logo
Biotechnology, Life Sciences, Medical Devices, Scientific Instruments, Pharmaceuticals

Staff Process Engineer

Rochester, NYOnsiteFull TimeStaff$103,100–$154,700 /yrPosted 1 month agoVisa sponsorship available

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Required skills

  • cGMP
  • FDA regulations
  • quality management systems
  • lean manufacturing
  • continuous improvement
  • data-driven decision making
  • validation protocols
  • risk assessment
  • mitigation strategies
  • regulatory compliance

Nice to have

  • pharmaceutical
  • medical device
  • biotechnology
  • Mechanical Engineering
  • Electrical Engineering
  • Chemical Engineering

Role summary

Thermo Fisher Scientific is seeking a Staff Process Engineer to provide technical leadership for complex manufacturing processes, equipment automation, and capital projects. This role involves enhancing production efficiency, ensuring product quality, and implementing advanced technologies within regulated industries like pharmaceutical, medical device, or biotechnology. The position requires strong analytical, problem-solving, and cross-functional leadership skills, with experience in cGMP, FDA regulations, lean manufacturing, and process validation. The ideal candidate will have an advanced degree plus 6 years of experience or a Bachelor's degree plus 8 years of experience in manufacturing engineering.

Work Schedule

First Shift (Days)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:
Join an innovative team at Thermo Fisher Scientific, where you'll advance manufacturing excellence and contribute to impactful solutions. As a Staff Manufacturing Engineer, you'll provide technical leadership for complex manufacturing processes, equipment automation, and capital projects. You'll collaborate across multiple functions to enhance production efficiency, ensure product quality, and implement advanced technologies. This role offers the opportunity to solve complex technical challenges while supporting our mission of enabling customers to make the world healthier, cleaner and safer.

REQUIREMENTS:
• Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in manufacturing engineering in regulated industries (pharmaceutical, medical device, or biotechnology preferred) or equivalent job experience
• Preferred Fields of Study: Engineering (Mechanical, Electrical, Chemical, Industrial or related field)
• Experience with cGMP, FDA regulations, and quality management systems
• Advanced knowledge of manufacturing processes, including clean room operations
• Demonstrated ability to enhance processes using lean manufacturing and continuous improvement methodologies
• Strong analytical and problem-solving skills with data-driven decision making
• Experience developing validation protocols and documentation for regulated environments
• Excellent cross-functional leadership and communication skills
• Ability to manage multiple concurrent projects in a dynamic environment
• Success record of implementing innovative technical solutions
• Experience mentoring engineers and technical staff
• Up to 10% travel may be required
• Proficiency with Microsoft Office suite and relevant engineering software packages
• Strong documentation and technical writing capabilities
• Experience with risk assessment and mitigation strategies
• Knowledge of safety protocols and regulatory compliance requirements

Compensation and Benefits

The salary range estimated for this position based in New York is $103,100.00–$154,700.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

  • A choice of national medical and dental plans, and a national vision plan, including health incentive programs

  • Employee assistance and family support programs, including commuter benefits and tuition reimbursement

  • At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

  • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

  • Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

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