Validation Engineer II
$70,000–$86,000 year
On-siteGrand Island, New York, United States
Job Summary
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 while supporting commissioning, startup, and qualification of new equipment and facility improvements. Partner with Engineering, Manufacturing, Quality, Maintenance, and Automation teams to solve technical problems, evaluate changes, and investigate validation deviations through root-cause analysis and corrective actions. Apply risk-based approaches to maintain clear, accurate, and inspection-ready GMP documentation, supporting internal audits and regulatory inspections. Maintain standard Mon-Fri schedule with on-site location in Grand Island, NY; PPE required.
Required 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
- 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
- Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Desired Qualifications
- 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
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