Validation Engineer – Regulated Diagnostics (Onsite)

ThermoFisher Scientific; Middletown (VA); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Medical and dental plans

Vision plan

Tuition reimbursement

Employee wellness programs

Job summary

Thermo Fisher Scientific in Middletown, Virginia is hiring a Validation Engineer for the Clinical Diagnostic Reagents (CDR) group. You will plan, execute, and document validation activities for clinical diagnostic reagent manufacturing in a cGMP, FDA-regulated, ISO 13485 environment.

This role collaborates with Engineering, Quality, and Manufacturing to maintain validated states. The position requires a Bachelor’s in Engineering/Life Sciences/Chemistry and 2+ years of relevant experience, with

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Chemistry or related field.
• 2+ years in validation, qualification, engineering, or quality in regulated environments.
• Experience authoring, reviewing, or executing IQ/OQ/PQ protocols.
• Strong technical writing and documentation skills.
• Ability to manage multiple priorities and collaborate cross-functionally.

Responsibilities

• Develop, execute, and document VMPs for facilities and equipment.
• Prepare IQ/OQ/PQ documentation and validation reports.
• Analyze validation data to ensure compliance with requirements.
• Support periodic validation reviews and remediation plans.
• Collaborate with Engineering, Quality, Manufacturing, and other teams.
• Assist audits and regulatory inspections as needed.

Skills

Validation engineering

Regulatory compliance

Technical writing

Cross-functional collaboration

Data analysis

Education

Bachelor’s degree in Engineering, Life Sciences, Chemistry

Tools

IQ/OQ/PQ protocols

Job description

Thermo Fisher Scientific in Middletown, Virginia is hiring a Validation Engineer for the Clinical Diagnostic Reagents (CDR) group. You will plan, execute, and document validation activities for clinical diagnostic reagent manufacturing in a cGMP, FDA-regulated, ISO 13485 environment.

This role collaborates with Engineering, Quality, and Manufacturing to maintain validated states. The position requires a Bachelor’s in Engineering/Life Sciences/Chemistry and 2+ years of relevant experience, with