Validation Engineering Tech [Remote]

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.)
Validation Engineer II

Grand Island, NY | On-site - Relocation assistance is not available.
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.

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.
Develop and execute validation and qualification activities for manufacturing equipment, facilities, utilities and processes.
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.
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.
• Experience That Will Help You Succeed

Equipment, facility or utility qualification.
HVAC, purified water, compressed air or manufacturing equipment.
GMP manufacturing and quality systems.
Risk-based validation approaches such as FMEA or ASTM E2500.
Engineering or capital-project execution.
Lean Manufacturing, PPI or other continuous-improvement methodologies.
Regulatory inspection or audit support.

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.
Partner with experienced colleagues across Engineering, Quality, Manufacturing, Automation and Maintenance.
Build skills in validation, engineering, quality systems, project execution and continuous improvement within a global science and technology organization.
Your work helps maintain reliable manufacturing operations and the quality systems that support products used by customers around the world.

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. 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