Process Engineer II
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Job Location:
Plainville, CT - USA
Monthly Salary:
$ 72600 - 108900
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Able to lift 40 lbs. without assistance Adherence to all Good Manufacturing Practices (GMP) Safety Standards OfficeJob Description
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.
Education
Bachelors degree in engineering science or related field.
Experience
- Minimum of 2 years experience in process development operations or engineering in a GMP-related industry.
Knowledge Skills Abilities
- 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.
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!
Other
- Relocation assistance is NOT provided
- 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
Compensation and Benefits
The salary range estimated for this position based in Massachusetts is $72600.00$108900.00.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: Experience:
IC
Key Skills
- Lean Manufacturing
- Six Sigma
- Distributed Control Systems
- Continuous Improvement
- Process Improvement
- Minitab
- Root cause Analysis
- Process Engineering
- cGMP
- Kaizen
- Programmable Logic Controllers
- Manufacturing
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
