Engineer II, Manufacturing Engineering

Thermo Fisher Scientific’s Clinical Diagnostic Reagents (CDR) group is seeking a Manufacturing Engineer II to provide engineering support for clinical diagnostic reagent manufacturing within a cGMP, FDA-regulated, and ISO 13485 environment.

This role will support the performance, reliability, optimization, and lifecycle management of high-volume, high-mix manufacturing operations, including formulation, filling, labeling, packaging, and associated manufacturing equipment and automation .

The Manufacturing Engineer II will provide day-to-day technical support to production while leading or supporting engineering initiatives that improve Overall Equipment Effectiveness (OEE), First Pass Yield (FPY), scrap, cycle time, changeover time, throughput, and equipment uptime . The engineer will troubleshoot manufacturing processes and equipment, implement tooling and equipment improvements, support automation initiatives, and use manufacturing data and structured problem-solving methods to drive sustainable improvements.

Working cross-functionally with Operations, Quality, R&D, Validation, Regulatory, and other partners, the Manufacturing Engineer II will support engineering projects throughout the manufacturing lifecycle—from scope and feasibility through implementation, qualification, sustainment, and eventual equipment or process obsolescence.

Location: Middletown, Virginia (fully onsite)

Relocation: Relocation assistance is not provided.

• ◆Provide day-to-day engineering support for manufacturing operations to improve product quality, yield, throughput, equipment reliability, and overall production performance.
• ◆Support the development, optimization, implementation, and sustainment of manufacturing processes used in diagnostic reagent production, including formulation, filling, labeling, and packaging operations .
• ◆Troubleshoot manufacturing equipment and process issues using structured problem-solving methods and implement sustainable corrective actions.
• ◆Monitor manufacturing performance and analyze production data to identify trends, constraints, sources of variation, and improvement opportunities.
• ◆Lead or support continuous improvement initiatives targeting OEE, FPY, scrap reduction, cycle time, changeover, throughput, and equipment uptime .
• ◆Develop and implement equipment, fixture, tooling, and manufacturing process improvements to enhance safety, ergonomics, quality, reliability, and productivity.
• ◆Identify and support opportunities for appropriate manufacturing automation and controls improvements .
• ◆Lead or support structured root cause investigations involving deviations, nonconformances, recurring process issues, and equipment failures.
• ◆Support CAPA development, implementation, and effectiveness activities in partnership with Quality and Operations.
• ◆Support equipment qualification, commissioning, and process validation activities, including applicable IQ/OQ/PQ and CQV activities .
• ◆Author, review, and revise controlled documentation, including SOPs, manufacturing work instructions, batch records, engineering specifications, and validation protocols/reports.
• ◆Support engineering change control and applicable Management of Change (MOC) activities.
• ◆Conduct or participate in risk assessments, including FMEA and other risk-analysis methodologies .
• ◆Partner with Operations, Quality, R&D, Validation, Regulatory, and other cross-functional stakeholders to support applicable cGMP, FDA, and ISO 13485 requirements.
• ◆Maintain accurate and complete engineering and manufacturing documentation consistent with applicable data-integrity requirements, including ALCOA+ principles .
• ◆Lead or support engineering projects from scope definition and feasibility assessment through implementation, qualification, sustainment, and lifecycle management.
• ◆Provide technical guidance and training to manufacturing personnel on new or modified processes, equipment, tooling, and work methods.
• ◆Support internal and external audits and regulatory inspections, as needed.
• ◆Manage multiple engineering priorities and projects within established production and project timelines.

• ✓Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Chemical Engineering, Biomedical/Biochemical Engineering, Manufacturing Engineering , or a related engineering or technical discipline.
• ✓2+ years of relevant manufacturing, industrial, process, equipment, or related engineering experience .
• ✓Experience supporting manufacturing processes and/or production equipment in a manufacturing or similarly technical environment.
• ✓Demonstrated ability to troubleshoot manufacturing processes or equipment using structured problem-solving methods.
• ✓Experience developing, reviewing, or maintaining engineering and/or manufacturing documentation.
• ✓Ability to analyze manufacturing data and use results to identify and implement process improvements.
• ✓Strong analytical, technic