Sr. Validation Engineer

Position Overview

We are seeking a Sr. Validation Engineer with 7–11 years of experience to lead validation activities across equipment, utilities, facilities, computerized systems, and manufacturing processes within GMP-regulated environments. This role is responsible for developing, executing, and managing validation lifecycle documentation while ensuring compliance with regulatory expectations and internal quality standards. The Sr. Validation Engineer will serve as a subject matter expert, support complex technical projects, and provide guidance to junior team members.

Key Responsibilities

• Lead the generation and execution of validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, utilities, facilities, cleaning processes, shipping systems, and other GMP-regulated assets.
• Oversee validation activities for internal and client tech transfer projects, including authoring, executing, reviewing, and closing validation documents such as risk assessments, validation plans, IQ, OQ, PQ, test methods, and validation reports.
• 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 summary reports for validation, verification, commissioning, and requalification activities.
• Develop and support procedures, investigations, protocols, reports, and change controls for Maintenance, Engineering, and Quality functions.
• Lead P&ID walkdowns to verify installation, configuration, and system readiness.
• Perform and oversee thermal mapping of temperature-controlled chambers, warehouses, and SIP processes.
• Support resolution of regulatory observations, audit findings, and manufacturing site issues related to validation.
• Lead periodic reviews and requalification activities for temperature-controlled systems and other validated assets.
• Provide technical mentorship and guidance to junior validation staff.
• Collaborate cross-functionally to ensure validation activities align with project timelines and operational needs.

Qualifications and Requirements

• Bachelor’s degree in a life science, engineering, or related technical field.
• 7–11 years of experience in the biotech, pharmaceutical, or medical device industry.
• Strong knowledge of FDA cGMP requirements, FMEA, and risk-based validation principles.
• Advanced validation expertise in equipment, computerized systems (CSV), analytical methods, and process validation.
• Extensive experience generating protocols for automated production systems, with emphasis on computerized equipment and systems validation.
• Demonstrated experience writing and reviewing IQ, OQ, PQ, and CSV reports.
• Experience supporting audits, regulatory inspections, and remediation activities.
• Strong verbal and written communication skills, with the ability to explain complex technical concepts to diverse audiences.
• Highly organized with strong documentation and analytical skills.
• Ability to lead validation workstreams, manage multiple priorities, and work independently.
• Strong problem-solving skills and experience supporting investigations and root-cause analysis.
• Ability to mentor junior engineers and contribute to team development.