Validation Engineer II
About The Position
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.
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.
Nice To Haves
- 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.
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.
Benefits
- Competitive compensation
- Annual incentive opportunity
- Healthcare benefits
- Range of employee benefits
- Opportunities for professional development and 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)
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
