Process Engineer II: High-Purity Water & Fluid Systems

ThermoFisher Scientific; Middletown (VA); On-site; USD 66,000 - 99,000; Full time

Benefits offered by this job

National medical plans

Dental plans

Vision plan

Employee assistance programs

Paid time off (PTO)

Paid holidays

Parental leave

401(k) plan

Employee Stock Purchase Plan (ESPP)

Job summary

Thermo Fisher Scientific is seeking a Process Engineer II for its Clinical Diagnostic Reagents group in Middletown, VA. The role focuses on design, optimization and lifecycle management of purified water systems, chemical formulation processes and sanitary fluid-handling equipment used in reagent manufacturing.

Lead or support capital projects, pursue improvements in OEE, FPY and process reliability while ensuring compliance with cGMP, FDA and ISO 13485 requirements in an onsite manufacturing

Qualifications

• Bachelor’s degree in Chemical, Mechanical, Biomedical/biochemical, Process, or Industrial Engineering.
• 2+ years of relevant engineering experience in manufacturing or technical setting.
• Ability to interpret and create PIDs, process flow diagrams, layouts and specifications.
• Mechanical/process design aptitude with lifecycle understanding.
• Strong analytical, troubleshooting and problem-solving skills.
• Excellent technical writing and documentation abilities.
• Effective multitasking across cross-functional teams.

Responsibilities

• Provide engineering leadership for high-purity water systems and sanitary fluid-handling.
• Design, evaluate, and optimize piping, pumps, valves, and instrumentation.
• Support chemical formulation, filtration and mixing operations in reagent manufacturing.
• Lead or support project activities from concept to commissioning and qualification.
• Improve OEE, FPY, scrap, cycle time, and uptime through sustainable fixes.
• Author SOPs, validation protocols, and change-control documentation.
• Support audits and regulatory inspections, drive CAPA and risk assessments.
• Collaborate with Quality, Validation, Facilities, and R&D to ensure compliance.
• Maintain data integrity and complete engineering records.

Skills

Engineering experience

FMEA & risk analysis

Documentation & reporting

Multi-priority management

Strong analytical skills

Communication skills

Education

Bachelor’s degree in Chemical/Mechanical/Biomedical/Process/Industrial Engineering

Tools

AutoCAD

SOLIDWORKS

Blue Mountain

MasterControl

SAP

Job description

Thermo Fisher Scientific is seeking a Process Engineer II for its Clinical Diagnostic Reagents group in Middletown, VA. The role focuses on design, optimization and lifecycle management of purified water systems, chemical formulation processes and sanitary fluid-handling equipment used in reagent manufacturing.

Lead or support capital projects, pursue improvements in OEE, FPY and process reliability while ensuring compliance with cGMP, FDA and ISO 13485 requirements in an onsite manufacturing