Engineer III, Computer Systems Validation

Description

Join our validation engineering team as a Validation Engineer III (Computer Systems Validation – CSV), where you will ensure product quality and regulatory compliance across pharmaceutical manufacturing operations. In this role, you will lead and execute validation activities with a strong focus on automation systems, computerized systems, and change management for existing commercial manufacturing lines. You will evaluate system and process changes, determine validation impact, and drive qualification strategies to ensure compliance with cGMP requirements. You will collaborate cross-functionally with automation, manufacturing, and quality teams while serving as a technical resource during regulatory inspections and client audits.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, or related technical field
• Equivalency: Equivalent combinations of education, training, and relevant experience may be considered in place of a degree
• Minimum of 4 years of validation experience in pharmaceutical/biotech manufacturing or comparable regulated industry
• Strong knowledge of cGMP regulations (FDA, EMA, ISO)
• Experience with Computer Systems Validation (CSV), CQV, or automation validation
• Experience writing and executing IQ/OQ/PQ validation protocols
• Experience with automation and control systems (PLC, SCADA, DCS, DeltaV, Allen-Bradley)
• Proven ability to lead validation projects and work cross-functionally
• Strong technical writing and documentation skills
• Experience with risk assessment methodologies and statistical analysis
• Advanced problem-solving and root cause analysis skills
• Excellent verbal and written communication skills
• Proficiency with MS Office and validation-related systems

Preferred

• Experience supporting or contributing to capital (CapEx) projects
• Experience with regulatory inspections and client audits
• Knowledge of lean manufacturing and continuous improvement methodologies