Validation Engineer II

About this role

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description

Validation Engineer II

Grand Island, NY | On-site - 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.

Build Your Career in Validation. Make an Impact That Matters. At Thermo Fisher Scientific, your engineering work helps enable our customers to make the world healthier, cleaner and safer.

We are looking for a Validation Engineer II to join our Grand Island manufacturing team. This is an excellent opportunity for an early-career engineer or validation professional who wants to build valuable experience in GMP manufacturing, equipment and facility qualification, process validation, capital projects and continuous improvement.

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.

What You’ll Do 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 will: • 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.

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 these 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.

What Makes This Opportunity Stand Out: Our total rewards offering includes competitive compensation, an annual incentive opportunity, healthcare benefits and a range of employee benefits, along with opportunities for professional development and career growth.

Build valuable technical expertise. Develop hands-on experience across equipment qualification, utilities, facilities, manufacturing processes and GMP validation. Work on meaningful projects. Support new equipment, facility improvements and manufacturing initiatives from startup through qualification. Learn across functions. Partner with experienced colleagues across Engineering, Quality, Manufacturing, Automation and Maintenance. Grow your career. Build skills in validation, engineering, quality systems, project execution and continuous improvement within a global science and technology organization. Make an impact. Your work helps maintain reliable manufacturing operations and the quality systems that support products used by customers around the world.

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 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: https://jobs.thermofisher.com/global/en/total-rewards

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