Engineer II, Validation

JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Warehouse, Will work with hazardous/toxic materials

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every day by enabling our customers to make the world healthier, cleaner and safer. We provide our global teams with resources to support individual career goals while advancing science and developing solutions for some of the world’s toughest challenges.

Position Summary

Thermo Fisher Scientific’s Clinical Diagnostic Reagents (CDR) group is seeking a Validation Engineer to support the planning, execution, and documentation of validation activities for clinical diagnostic reagent manufacturing within a cGMP, FDA-regulated, and ISO 13485 environment .

This role supports the qualification and validation lifecycle for manufacturing equipment, processes, facilities, utilities, and applicable systems. The Validation Engineer will develop and execute validation protocols, analyze results, prepare validation documentation, and support periodic reviews and gap assessments to maintain validated states and continued compliance with site and regulatory requirements.

The position works cross-functionally with Engineering, Quality, Manufacturing, and other site partners and receives guidance from senior validation engineering resources.

Location: Middletown, Virginia (fully onsite)
Relocation: Relocation assistance is not provided.

Key Responsibilities

• Support the development, implementation, and maintenance of Validation Master Plans (VMPs) for facility equipment, systems, utilities, and manufacturing processes.
• Author, revise, review, and execute validation and qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation.
• Analyze validation data and document results to verify that equipment, systems, and processes meet predefined requirements and acceptance criteria.
• Prepare validation reports and supporting documentation in accordance with applicable site procedures and quality-system requirements.
• Participate in periodic validation reviews, gap assessments, and lifecycle evaluations to help ensure systems and processes remain in a validated state.
• Identify validation gaps and collaborate with appropriate stakeholders to develop and implement remediation plans.
• Apply risk-based approaches to validation planning, execution, and documentation.
• Collaborate with Engineering, Quality, Manufacturing, and other cross-functional partners to plan and coordinate validation activities.
• Support validation deviations, investigations, root cause analyses, CAPAs, and associated corrective and preventive actions.
• Support change-control activities involving validated equipment, processes, utilities, and systems, including assessment of potential validation impact.
• Maintain accurate and complete validation records in accordance with site quality systems and applicable data-integrity requirements.
• Support calibration coordination, verification activities, and documentation associated with equipment used in validated processes.
• Support validation activities associated with applicable automation and computerized systems.
• Contribute to continuous improvement of site validation practices, templates, procedures, and documentation.
• Support internal and external audits and regulatory inspections, as needed.
• Manage assigned validation activities and priorities to meet established project and production timelines.

Minimum Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Chemistry , or a related scientific or technical discipline.
• 2+ years of relevant validation, qualification, engineering, or quality experience in a regulated or similarly controlled environment.
• Experience authoring, reviewing, and/or executing validation or qualification documentation, including IQ, OQ, and/or PQ protocols .
• Strong technical writing and documentation skills.
• Strong analytical, data-review, and problem-solving capabilities.
• Ability to interpret technical requirements, evaluate results against predefined acceptance criteria, and document conclusions clearly.
• Ability to manage multiple assignments and priorities within established timelines.
• Ability to collaborate effectively with cross-functional teams.
• Proficiency with Microsoft Office applications, including Word, Excel, Outlook, and PowerPoint.
• Ability to work onsite and enter manufacturing and cleanroom environments as required.

Knowledge and Skills

• Understanding of validation and qualification lifecycle principles.
• Familiarity with cGMP and regulated quality-system requirements .
• Familiarity with risk-based quality and problem-solving methodologies such as FMEA, risk analysis, root cause analysis, and CAPA .
• Understanding of change control and its relationship to maintaining validated systems and processes.
• Strong attention to detail and commitment to accurate, traceable, and complete documentation.
• Effective written and verbal communication skills.
• Ability to work both independently on assigned activities and collaboratively within cross-functional teams.

Preferred Qualifications

• Validation or qualification experience within medical device, diagnostics, pharmaceutical, biotechnology, or other regulated manufacturing environments .
• Working knowledge of applicable FDA regulations, ISO 13485, GAMP 5, and cGMP requirements .
• Experience developing and executing IQ/OQ/PQ protocols for manufacturing equipment, processes, facilities, utilities, or related systems.
• Experience with risk-based validation methodologies and validation lifecycle management.
• Experience supporting periodic reviews, validation gap assessments, and remediation activities .
• Experience supporting deviations, investigations, root cause analysis, CAPA, and change control.
• Familiarity with calibration and metrology principles .
• Experience with manufacturing automation and/or computerized system validation (CSV) .
• Familiarity with electronic quality management systems or validation/document-management systems.
• Knowledge of statistical analysis, process capability, or statistical process control methods.
• Experience supporting audits or regulatory inspections in a regulated manufacturing environment.

Core Competencies

• Analytical thinking and structured problem solving.
• Clear and concise technical communication.
• Strong organization and attention to detail.
• Effective cross-functional collaboration.
• Ability to balance multiple priorities and meet established deadlines.
• Commitment to quality, compliance, and continuous improvement.

Compensation and Benefits

The salary range estimated for this position based in Virginia is $60,000.00–$90,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: