Thermo Fisher Scientific · 15 hours ago
Process Engineer
Allentown, Pennsylvania, USA
Full-time
Onsite
Mid, Senior Level
3+ years expThermo Fisher Scientific is a leading company in the pharmaceutical packaging industry, and they are seeking a Process Engineer to support their Engineering and Operations teams. The role involves leading technology transfers, driving capital equipment projects, and optimizing operational efficiency in a GMP-regulated environment.
Research
Responsibilities
Ensure full compliance with GMP standards, site safety practices, and what we value (Integrity, Intensity, Innovation, Involvement)
Assist in ongoing improvement efforts aimed at cutting costs, boosting efficiency, enhancing product quality, and streamlining workflow
Lead technology transfer activities for new and existing client products, including documentation, qualification, and alignment to project timelines
Drive capital expenditure (CAPEX) projects from initiation through equipment installation and operational integration
Develop equipment specifications and user requirements (URS or equivalent experience), lead vendor evaluations, drive design reviews, and perform FAT/SAT, commissioning, and validation activities
Onboard and integrate new equipment, automation platforms, and production technologies to improve throughput, reduce manual operations, and enhance control
Collaborate with Production and Operations to identify and resolve workflow bottlenecks and performance constraints across packaging lines
Support in resolving complex issues on packaging equipment, working closely with maintenance, OEMs, and operators to identify root causes and implement sustainable solutions
Conduct deviation investigations, CAPAs, and change control management
Review, develop, and approve Engineering and Validation documents, including protocols, specifications, and SOPs
Perform additional duties as needed to meet business and operational objectives
Qualification
Required
At least 3 years of engineering experience in a relevant cGMP controlled environment, with a preference for the pharmaceutical or food industry
A four-year, Bachelor of Science degree from an accredited college or university in Packaging, Electrical, Mechanical, or Industrial Engineering or a related field
Proficiency in pharmaceutical or food packaging operations
Strong foundation in Lean, Six Sigma, SMED, and structured problem-solving methodologies
Mechanical proficiency with proven experience resolving issues with packaging equipment
Proficient in authoring equipment onboarding and qualification documentation (URS, FDS, FMEAs, FAT/SAT/Commissioning protocols, SOPs, Work Instructions)
Strong written and verbal communication skills with the ability to explain technical information to non-technical collaborators, including clients
Proficiency with MS Office, especially Excel, for data analysis and project tracking
Ability to occasionally lift up to 10 lbs. and perform activities such as bending, reaching, and standing as needed
Preferred
5-10 years of experience in a relevant cGMP controlled environment
Experience with automated packaging, labeling, bottling, or device assembly equipment
Company
Thermo Fisher Scientific
The world leader in serving science To serve science, Thermo Fisher Scientific needs to stay ahead of it, we need to anticipate customer needs.
10001+ employees
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (272)
2024 (224)
2023 (233)
2022 (342)
2021 (315)
2020 (227)
Funding
Current Stage
Late StageLeadership Team
Heather Stewart
HR Business Partner - Global Enterprise Services
Laura Green
Associate Human Resources Business Partner
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