Process Engineer II
Listed on 2026-07-20
-
Engineering
Process Engineer, Quality Engineering, Manufacturing Engineer, Biomedical Engineer
Process Engineer II
Thermo Fisher Scientific's Clinical Diagnostic Reagents (CDR) group is seeking a Process Engineer II to support the design, optimization, validation, and lifecycle management of purified water systems, chemical formulation processes, and sanitary fluid handling equipment used in clinical diagnostic reagent manufacturing.
This role will provide technical leadership and system design optimization for high purity water generation and chemical formulation processes including storage and distribution, filtration, piping, pumps, valves, and mixing systems equipment within a cGMP, FDA, and ISO 13485 regulated environment. This position will lead or assist with mechanical and process design initiatives, improvement of manufacturing reliability and throughput, support of capital projects from concept through commissioning, and partner with Operations, Facilities, Quality, Validation, and R&D to ensure successful delivery of engineering projects.
This position will help drive end-to-end performance of multiple high-volume and high-mix manufacturing lines with a variety of equipment with various levels of automation. They will help lead cross-functional execution of engineering projects and deliver measurable gains in OEE, FPY, scrap, cycle time, changeover, and equipment uptime. They will also help drive engineering improvement initiatives, including tooling and equipment design and automation, and must be able to manage multiple projects simultaneously from scope and feasibility assessment through sustainment and end of life obsolescence.
Key Responsibilities
Lead engineering support for high purity water systems including pre-treatment, RO/DI generation, UV sanitization, storage, distribution loops, and point-of-use delivery.
Design and optimize sanitary fluid handling systems including piping, pumps, valves, tubing, manifolds, instrumentation, and process connections.
Support chemical formulation, buffer preparation, bulk solution transfer, and mixing operations for diagnostic reagent manufacturing.
Develop and revise P&IDs, process flow diagrams, equipment specifications, and engineering documentation.
Lead or assist with equipment specification, vendor selection, FAT/SAT, commissioning, qualification (IQ/OQ/PQ), and startup activities.
Troubleshoot fluid process equipment and implement improvements to increase reliability, quality, throughput, and OEE and reduce error occurrences.
Author and revise SOPs, work instructions, validation protocols, and change control documentation.
Lead deviation investigations, CAPAs, root cause analysis, and risk assessments (FMEA).
Partner with Quality, Validation, Facilities, Manufacturing, and R&D to ensure cGMP and ISO 13485 compliance.
Support continuous improvement and capital engineering projects through the entire design lifecycle.
Maintain accurate documentation in compliance with data integrity standards (ALCOA+) and assist with change control activities (MOC, COs, etc.).
Support internal and external audits and regulatory inspections as needed.
Minimum Requirements / Qualifications
Bachelor's degree in Chemical Engineering, Mechanical Engineering, Biomedical/Biochemical Engineering, or Process/Industrial Engineering (or related discipline).
2-3 years of engineering experience in regulated manufacturing (medical device, diagnostics, biotechnology, or pharmaceutical preferred). Experience with purified water, fluid handling, or liquid chemical formulation strongly preferred.
Knowledge & Skills Requirements
Strong mechanical design aptitude and familiarity with equipment and process design lifecycle components from conception through end of line obsolescence.
Strong ability to create, review, understand and communicate necessary fluid handling design documentation such as P&, layouts, etc.
Working knowledge of cGMP, Aseptic Filling, FDA regulations (21 CFR Part 820/210/211), ISO 13485, and hygienic design principles (ASME BPE preferred).
Strong analytical and problem-solving skills.
Ability to work both independently and in a team-oriented environment.
Familiarity with risk-based validation concepts and validation lifecycle documentation (IQ/OQ/PQ).
Familiar…
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).