Process Engineer II

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&ID dwgs, 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 with quality improvement tools (FMEA, Risk Analysis, Root Cause Analysis).

Familiarity with CMMS/electronic quality systems (Blue Mountain, MasterControl, SAP preferred) and CAD software such as AutoCAD/Solidworks or similar.

Proficient in Microsoft Office Suite (Excel, Word, Outlook, PowerPoint).

Strong technical writing and documentation practices

Personal Attributes

Strong written and verbal communication skills.

Ability to work both independently and in a cross-functional team-oriented environment.

Willingness to learn and continuously develop knowledge and skills.

Ability to manage multiple tasks within a structured project timeline.

Attention to detail and commitment to quality.

Proactive mindset with continuous improvement focus.

Comfortable working onsite in a manufacturing/production environment.

Preferred Qualifications

Experience supporting purified water systems (RO/DI), filtration systems, reagent formulation, or sanitary fluid process equipment in diagnostics, biotech, or pharmaceutical manufacturing.

Experience with pump sizing, process piping, skid design, mixing systems, and equipment commissioning is highly desirable.

Familiarity with Continuous Improvement and Lean Six Sigma principles (LSS Green / Black Belt a bonus).

Knowledge of aseptic processing, validation, and process automation are desirable.