Manufacturing Engineer II - Diagnostic Reagents Ops

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

Benefits offered by this job

Medical plan

Dental plan

Vision plan

PTO 120 hours

Tuition reimbursement

ESPP

401(k)

Job summary

Thermo Fisher Scientific, within its Clinical Diagnostic Reagents (CDR) group, is seeking a Manufacturing Engineer II to support high‑volume, high‑mix reagent manufacturing in a cGMP, FDA‑regulated, ISO 13485 environment.

You will contribute to process optimization, equipment uptime, and lifecycle management across formulation, filling, labeling, and packaging while collaborating with Quality, R&D, Validation, Regulatory, and Operations teams. This is an onsite role based in Middletown, VA.

Qualifications

• 2+ years of manufacturing/industrial/process/equipment engineering experience.
• Ability to troubleshoot manufacturing processes or equipment using structured problem-solving methods.
• Experience developing, reviewing, or maintaining engineering/manufacturing documentation.
• Ability to analyze manufacturing data and drive process improvements.
• Ability to work onsite in a manufacturing environment with PPE/gowning requirements.

Responsibilities

• Provide day-to-day engineering support to improve product quality, yield, throughput, and equipment reliability.
• Support development and sustainment of processes for diagnostic reagent production (formulation, filling, labeling, packaging).
• Troubleshoot equipment/process issues and implement corrective actions.
• Monitor performance and analyze data to identify trends and opportunities for improvement.
• Lead or support CAPA, change control, risk assessments, and validation activities.

Skills

Analytical thinking

Strong communication

Problem solving

Team collaboration

Documentation

Education

Bachelor's degree in Mechanical/Industrial/Chemical/Biomedical Manufacturing Engineering

Tools

CAD software

Microsoft Office

Job description

Thermo Fisher Scientific, within its Clinical Diagnostic Reagents (CDR) group, is seeking a Manufacturing Engineer II to support high‑volume, high‑mix reagent manufacturing in a cGMP, FDA‑regulated, ISO 13485 environment.

You will contribute to process optimization, equipment uptime, and lifecycle management across formulation, filling, labeling, and packaging while collaborating with Quality, R&D, Validation, Regulatory, and Operations teams. This is an onsite role based in Middletown, VA.