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Thermo Fisher Scientific · 1 day ago

Process Engineer II

Plainville, MA

Full-time

Onsite

Entry, Mid Level

$73K/yr - $109K/yr

2+ years exp

Thermo Fisher Scientific is a leading company in the life sciences sector, and they are seeking a Process Engineer II to support clinical and commercial drug manufacturing. The role involves designing and supporting manufacturing equipment, collaborating with various teams to ensure compliance with safety and quality standards.

BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine

No H1B

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

Qualification

CGMP standardsProcess equipmentBioreactorsChromatographyTFF systemsAutoclavesEngineering documentationPreventative maintenanceHigh ethical standardsTeam collaboration

Required

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

Able to lift 40 lbs. without assistance

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

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