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 provides technical engineering support and leadership for high-purity water generation storage and distribution systems as well as chemical formulation processes and associated equipment including filtration systems piping pumps valves instrumentation and mixing systems. The position operates within a cGMP FDA-regulated and ISO 13485 environment.

The Process Engineer II will lead or support mechanical and process design initiatives manufacturing reliability and throughput improvements and capital projects from concept and feasibility through commissioning qualification sustainment and end-of-life management. The engineer will collaborate closely with Operations Facilities Quality Validation R&D and other cross-functional partners to deliver successful engineering projects.

The role will also support the performance of high-volume high-mix manufacturing operations with equipment spanning varying levels of automation. The engineer will contribute to measurable improvements in Overall Equipment Effectiveness (OEE) First Pass Yield (FPY) scrap cycle time changeover time and equipment uptime while managing multiple engineering priorities and projects.

Location: Middletown VA (fully onsite)

• Provide engineering support and technical leadership for high-purity water systems including pretreatment RO/DI generation UV treatment/sanitization storage distribution loops and point-of-use delivery.
• Design evaluate and optimize sanitary fluid-handling systems including piping pumps valves tubing manifolds instrumentation process connections and related equipment.
• Support chemical formulation buffer preparation bulk solution transfer filtration and mixing operations used in diagnostic reagent manufacturing.
• Develop review and revise P&IDs process flow diagrams equipment specifications layouts and other engineering documentation.
• Lead or support equipment specification vendor evaluation and selection FAT/SAT commissioning qualification activities (IQ/OQ/PQ) and production startup.
• Troubleshoot process and manufacturing equipment and implement sustainable improvements to increase reliability product quality throughput OEE and equipment uptime while reducing process errors and scrap.
• Support equipment tooling process design and automation improvement initiatives throughout the engineering lifecycle.
• Author and revise SOPs work instructions validation protocols engineering reports and change-control documentation.
• Lead or support deviation investigations CAPAs root cause analyses FMEAs and other risk assessments.
• Partner with Quality Validation Facilities Manufacturing Operations and R&D to support compliance with applicable cGMP FDA and ISO 13485 requirements.
• Support continuous improvement and capital engineering projects from initial scope and feasibility assessment through implementation sustainment and end-of-life/obsolescence management.
• Maintain complete and accurate engineering documentation consistent with applicable data-integrity principles including ALCOA and support applicable change-management processes.
• Support internal and external audits and regulatory inspections as required.
• Manage multiple engineering projects and priorities within established project timelines.

• Bachelors degree in Chemical Engineering Mechanical Engineering Biomedical/Biochemical Engineering Process Engineering Industrial Engineering or a related engineering discipline.
• 2 years of relevant engineering experience in a manufacturing or similarly technical environment.
• Demonstrated ability to interpret create review or communicate engineering documentation such as P&IDs process flow diagrams equipment layouts and technical specifications.
• Demonstrated mechanical and/or process design aptitude and understanding of the equipment or process lifecycle.
• Strong analytical troubleshooting and problem-solving skills.
• Strong technical writing and documentation skills.
• Ability to manage multiple priorities and work effectively both independently and within cross-functional teams.
• Proficiency with Microsoft Office applications including Excel Word Outlook and PowerPoint.

• Understanding of process and mechanical engineering principles related to fluid handling manufacturing equipment and process systems.
• Familiarity with regulated manufacturing practices and applicable quality systems.
• Familiarity with risk assessment and problem-solving methodologies such as FMEA root cause analysis and risk analysis.
• Ability to communicate technical information effectively to engineering and non-engineering stakeholders.
• Strong attention to detail and commitment to quality safety documentation and continuous improvement.
• Ability to work effectively in an onsite manufacturing and production environment.

• Engineering experience in a regulated medical device diagnostics biotechnology pharmaceutical or similarly regulated manufacturing environment.
• Experience supporting purified water systems (RO/DI) filtration systems reagent or chemical formulation sanitary fluid-handling systems or liquid-processing equipment.
• Experience with pump sizing process piping skid design mixing systems bulk fluid transfer and/or equipment commissioning.
• Working knowledge of cGMP aseptic processing FDA regulations ISO 13485 and hygienic/sanitary design principles.
• Familiarity with ASME BPE principles or standards.
• Experience with risk-based validation and qualification lifecycle documentation including IQ/OQ/PQ.
• Experience with deviation investigations CAPA change control and regulated quality-system documentation.
• Familiarity with CMMS and/or electronic quality systems such as Blue Mountain MasterControl SAP or comparable platforms.
• Familiarity with AutoCAD SOLIDWORKS or comparable CAD/design software.
• Knowledge of process automation and controls in a manufacturing environment.
• Familiarity with Lean Six Sigma or other continuous improvement methodologies; Green Belt or Black Belt certification is a plus.

• Clear and effective written and verbal communication.
• Collaborative approach to working across technical and operational functions.
• Ability to independently organize work and execute within structured project timelines.
• Proactive approach to identifying and solving manufacturing and engineering challenges.
• Strong attention to detail and commitment to quality.
• Continuous-learning mindset and willingness to develop new technical capabilities.