Validation Engineer II

Validation Engineer II

Location: Grand Island, NY (On-site)

Relocation assistance: Not available.

Work Schedule

Standard (Mon–Fri)

Environmental Conditions

• Adherence to Good Manufacturing Practices (GMP) and safety standards
• Office environment and some degree of PPE required (e.g., safety glasses, gowning, gloves, lab coat, ear plugs)

Job Description

Thermo Fisher Scientific is seeking a Validation Engineer II to join the Grand Island manufacturing team. This role is an excellent opportunity for an early-career engineer or validation professional to build experience in GMP manufacturing, equipment and facility qualification, process validation, capital projects, and continuous improvement.

You will work with Engineering, Manufacturing, Quality, Maintenance, and Automation teams, supporting projects with meaningful impact on operations and customers.

What You’ll Do

• Develop and execute validation and qualification activities for manufacturing equipment, facilities, utilities, and processes
• Author and execute IQ, OQ, and PQ protocols, validation plans, and summary reports
• Support commissioning, startup, and qualification of new equipment and facility improvements
• Partner with cross-functional teams to solve technical problems and deliver projects successfully
• Evaluate changes to equipment and processes and determine validation or requalification requirements
• Investigate validation deviations and support root-cause analysis and corrective actions
• Apply risk-based approaches to validation and qualification activities
• Maintain clear, accurate, inspection-ready GMP documentation
• Support internal audits and regulatory inspections
• Identify opportunities to simplify, standardize, and continuously improve validation processes

What You’ll Bring

Minimum Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline
• 1–2 years of experience in validation, engineering, manufacturing, quality, or another relevant technical environment (internship experience included)
• Experience working in, or exposure to, a regulated or quality-driven manufacturing environment
• Strong technical writing, problem-solving, and communication skills
• Ability to work effectively with cross-functional teams

Experience That Will Help You Succeed

Relevant experience in one or more of the following areas is valuable but not required:

• IQ/OQ/PQ or process validation
• Equipment, facility, or utility qualification
• HVAC, purified water, compressed air, or manufacturing equipment
• GMP manufacturing and quality systems
• Change control, deviations, root-cause investigations, or CAPA
• Risk-based validation approaches such as FMEA or ASTM E2500
• GAMP 5 and computerized system validation
• Engineering or capital-project execution
• Lean Manufacturing, PPI, or other continuous-improvement methodologies
• Regulatory inspection or audit support

Compensation and Benefits

The salary range estimated for this position based in New York is $70,000.00–$86,000.00.

This position may also be eligible for a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. A comprehensive Total Rewards package may include:

• 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 a competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP), offering eligible colleagues the opportunity to purchase company stock at a discount

For more information on benefits, visit: https://jobs.thermofisher.com/global/en/total-rewards

Other Information

• Relocation assistance is not available.
• Candidates must be legally authorized to work in the United States without sponsorship.
• Employment is contingent upon successful completion of applicable pre-employment requirements, including a background check and drug screening.