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About the Role

As a Validation Engineer II, you will help ensure our manufacturing equipment, facilities, utilities and processes operate reliably and meet applicable quality and regulatory requirements. You’ll work directly with Engineering, Manufacturing, Quality, Maintenance and Automation teams and gain hands-on exposure to projects that have a meaningful impact on our operations and the customers we serve.

Responsibilities

• 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 the commissioning, startup and qualification of new equipment and facility improvements.
• Partner with Engineering, Manufacturing, Quality, Maintenance and Automation teams to solve technical problems and successfully deliver projects.
• 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 and inspection-ready GMP documentation.
• Support internal audits and regulatory inspections.
• Identify opportunities to simplify, standardize and continuously improve validation processes.

Requirements

• 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.
• 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.

Skills

• IQ/OQ/PQ
• Process validation
• Equipment qualification
• Facility qualification
• Utility qualification
• HVAC
• Purified water
• Compressed air
• Manufacturing equipment
• GMP manufacturing
• Quality systems
• Change control
• Deviations
• Root-cause investigations
• CAPA
• Risk-based validation approaches
• FMEA
• ASTM E2500
• GAMP 5
• Computerized system validation
• Engineering project execution
• Capital-project execution
• Lean Manufacturing
• PPI
• Continuous-improvement methodologies
• Regulatory inspection support
• Audit support

Location

• Grand Island, NY

Work Type

• On-site
• Standard (Mon-Fri)

Experience Level

• Early-career
• 1-2 years

Education Level

• Bachelor's degree

Salary/Compensations

• $70,000.00–$86,000.00

Benefits

• Competitive compensation
• Annual incentive opportunity
• Healthcare benefits
• Range of employee benefits
• Opportunities for professional development
• Career growth
• Choice of national medical and dental plans
• National vision plan
• Health incentive programs
• Employee assistance and family support programs
• Commuter benefits
• 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
• Short- and long-term disability
• Retirement and savings programs
• Competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP)

About the Company

• At Thermo Fisher Scientific, your engineering work helps enable our customers to make the world healthier, cleaner and safer.