Sr. Validation Engineer

About the role

We are seeking a Sr. Validation Engineer with 7-11 years of experience to lead and support validation activities across equipment, utilities, facilities, computerized systems, manufacturing processes, and MES/eBR platforms within GMP-regulated environments. This role is responsible for developing, executing, reviewing, and managing validation lifecycle documentation while ensuring compliance with regulatory expectations, data integrity requirements, and internal quality standards. The Sr. Validation Engineer will serve as a subject matter expert for validation and computerized systems, providing QA/Validation oversight for Manufacturing Execution System (MES) and Electronic Batch Record (eBR) implementations, qualification activities, and system lifecycle management. This individual will partner closely with Manufacturing, Quality, Validation, Automation, and IT/OT teams to ensure successful system deployment, qualification, and ongoing compliance.

Responsibilities

• Lead the generation and execution of validation lifecycle documentation (FAT, SAT, IQ, OQ, PQ) for equipment, utilities, facilities, cleaning processes, shipping systems, computerized systems, and other GMP-regulated assets.
• Provide QA/Validation oversight for MES and eBR implementation, qualification, and system lifecycle activities.
• Review and approve requirements, risk assessments, traceability matrices, validation plans, test protocols, deviations, change controls, and validation summary reports.
• Review eBR workflows and electronic manufacturing processes to ensure alignment with approved manufacturing procedures, master batch records, and GMP requirements.
• Ensure compliance with applicable regulatory requirements, including 21 CFR Part 11, GMP, data integrity, computerized systems validation (CSV), and industry best practices.
• Support deviation investigations, CAPAs, change controls, system releases, and go-live readiness activities for MES/eBR and other GMP computerized systems.
• Oversee validation activities for internal and client technology transfer projects, including authoring, executing, reviewing, and closing validation documentation.
• Write, review, and revise qualification and verification documents, including SOPs, Validation Master Plans, execution plans, URS, FRS, design specifications, FAT documentation, verification protocols, and commissioning test procedures.
• Prepare comprehensive validation, verification, commissioning, qualification, and requalification summary reports.
• Develop and support procedures, investigations, protocols, reports, and change controls for Maintenance, Engineering, Manufacturing, and Quality functions.
• Lead P&ID walkdowns to verify installation, configuration, and system readiness.