Engineer III, Computer Systems Validation
Thermo Fisher Scientific
Validation Engineer III leading computer systems validation and change management activities for pharmaceutical manufacturing operations. Ensures regulatory compliance across automation systems, computerized platforms, and manufacturing processes while collaborating with cross-functional teams.
Responsibilities
- Lead validation activities for equipment, processes, utilities, and computer systems with CSV focus
- Evaluate and support change management for existing manufacturing systems and automation platforms
- Author, review, and execute validation documentation including IQ/OQ/PQ protocols and qualification plans
- Perform risk assessments, gap analyses, and validation assessments independently
- Provide technical expertise during regulatory inspections and client audits
Requirements
- Bachelor's degree in Engineering, Life Sciences, Chemistry, or related technical field
- Minimum 4 years validation experience in pharmaceutical/biotech manufacturing or regulated industry
- Strong knowledge of cGMP regulations (FDA, EMA, ISO)
- Experience with Computer Systems Validation, CQV, or automation validation
- Proficiency with automation control systems (PLC, SCADA, DCS, DeltaV, Allen-Bradley)
- Proven ability to lead validation projects and work cross-functionally
- Experience writing and executing IQ/OQ/PQ validation protocols
Vacancy posted 5 days ago
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