Process Engineer II

Thermo Fisher Scientifics 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 leadershipand system design optimizationforhigh puritywater generationand chemicalformulationprocessesincludingstorage and distribution filtration piping pumps valvesandmixing systemsequipment within a cGMP FDA and ISO 13485 regulated environment.

This positionwill leador assist withmechanical and process design initiatives improvement ofmanufacturing reliability and throughput supportofcapital projects from concept through commissioning and partner withOperations Facilities Quality Validation and R&Dto ensure successful delivery of engineering projects.

This positionwillhelpdriveend-to-end performance ofmultiplehigh-volume and high-mix manufacturing lines with a variety of equipment with various levels of automation.They willhelp leadcross-functional executionof engineering projectsand deliver measurable gains in OEE FPY scrap cycle time changeover andequipmentuptime.They will also help driveengineering improvement initiatives including tooling and equipment design and automation andmust beable tomanage multiple projectssimultaneouslyfrom scopeand feasibility assessmentthrough sustainment and end of life obsolescence.

Key Responsibilities

Lead engineering support forhigh puritywater systems including pre-treatment RO/DI generationUV sanitizationstorage distribution loopsand 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.

Leador assist withequipment 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 OEEand reduce erroroccurences

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 projectsthrough 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

Bachelors degree inChemicalEngineering Mechanical

EngineeringBiomedical/BiochemicalEngineering orProcess/Industrial Engineering (or related discipline).

2-3years of engineering experience in regulated manufacturing (medical device diagnostics biotechnology or pharmaceutical preferred). Experience with purified water fluid handling orliquid chemical formulationstronglypreferred.

Knowledge & SkillsRequirements

Strong mechanical design aptitude andfamiliarity with equipment and process design lifecycle components from conception through end of line obsolescence.

Strong ability to create review understand and communicate necessaryfluid handlingdesign documentation such as P&IDdwgs layouts etc.

Working knowledge of cGMPAseptic FillingFDA 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 conceptsand validation lifecycle documentation (IQ/OQ/PQ).

Familiar withqualityimprovementtools (FMEA Risk Analysis Root Cause Analysis).

Familiarity with CMMS/electronic quality systems (Blue Mountain MasterControl SAP preferred) and CAD software such as AutoCAD/Solidworksor 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 across-functionalteam-oriented environment.

Willingness to learnand 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 withContinuous Improvement andLeanSix Sigma principles(LSS Green / Black Belt a bonus).

Knowledgeof aseptic processing validation and process automation are desirable.