Process Engineer II

Thermo Fisher Scientific • Plainville, MA

4d • Onsite

About The Position

Process Engineer II will support the clinical and commercial drug manufacturing in Plainville, MA. Scope includes designing, specifying, and supporting manufacturing equipment such as fill lines, bioreactors, chromatography and TFF systems, autoclaves, and analytical equipment in our recently built viral vector facility. The individual will join a dedicated team of process engineers working closely with groups such as manufacturing, automation, quality assurance, quality control and validation. Responsibilities: Implement manufacturing equipment involved in tech transfers of new products into manufacturing and provide continued engineering support throughout manufacturing campaigns. Support all aspects of the process equipment for upstream, downstream, and fill/finish operations, including support of FAT, SAT, and commissioning/qualification activities. Participate and lead site teams for process equipment introduction and modification. Develop equipment specifications for manufacturing equipment and prepare lifecycle documentation such as user requirements, instrument assessments, and preventative maintenance plans. Build and maintain relationships within the Plainville site to develop and promote engineering standard methodologies and ensure compliance with SOPs, safe work practices, and cGMP regulations. The position involves close collaboration with Manufacturing, Manufacturing Sciences, Quality Assurance, Quality Control, and other Engineering teams. Position requires ability to support on-call requirements for client programs. Colleagues will be readily available to respond to production needs outside of core business hours ensuring business continuity. The on-call responsibilities typically rotate weekly through the engineering team.

Requirements

• Bachelor’s degree in engineering, science or related field.
• Minimum of 2 years experience in process development, operations, or engineering in a GMP-related industry.
• Working understanding of general cGMP standards and practices
• Understanding of process equipment and unit operations (Bioreactors, Chromatography, TFF, Autoclaves, media/buffer preparation, etc.) and associated process utility systems
• Comfortable supporting concurrent issues and working in an exciting and fast-paced environment.
• High ethical standards to support a professional business code of conduct.
• Must be legally authorized to work in the United States now and in the future, without sponsorship.
• Must be able to pass a comprehensive background check, which includes a drug screening

Responsibilities

• Implement manufacturing equipment involved in tech transfers of new products into manufacturing and provide continued engineering support throughout manufacturing campaigns.
• Support all aspects of the process equipment for upstream, downstream, and fill/finish operations, including support of FAT, SAT, and commissioning/qualification activities.
• Participate and lead site teams for process equipment introduction and modification.
• Develop equipment specifications for manufacturing equipment and prepare lifecycle documentation such as user requirements, instrument assessments, and preventative maintenance plans.
• Build and maintain relationships within the Plainville site to develop and promote engineering standard methodologies and ensure compliance with SOPs, safe work practices, and cGMP regulations.
• Position requires ability to support on-call requirements for client programs. Colleagues will be readily available to respond to production needs outside of core business hours ensuring business continuity. The on-call responsibilities typically rotate weekly through the engineering team.

Benefits

• We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.
• Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects.
• We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees