Process Engineer II

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Rapid flashing lights, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

Job Description

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, improv ement 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.

Th is 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   t hrough 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   occurences

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   q uality   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.