Validation Engineer

Position Summary

The Validation Engineer is responsible for planning, executing, documenting, and maintaining qualification and validation activities supporting GMP manufacturing operations. This role ensures facilities, utilities, equipment, computerized systems, cleaning processes, sterilization processes, and manufacturing processes are qualified and maintained in compliance with CGMP requirements while supporting clinical and commercial pharmaceutical manufacturing.

Essential Responsibilities

• Develop, execute, review, and maintain qualification and validation protocols and reports, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Process Performance Qualification (PPQ), Cleaning Validation, Sterilization Validation, and Validation Summary Reports (VSR).
• Support the development and execution of Computer System Validation (CSV).
• Lead qualification and validation activities for facilities, cleanrooms, utilities, manufacturing equipment, laboratory equipment, analytical instruments, and computerized systems.
• Develop and review User Requirements Specifications (URS), Functional Requirements Specifications (FRS), Design Specifications (DS), traceability matrices, and validation plans.
• Review vendor documentation including drawings, P&IDs, manuals, FAT/SAT documentation, and technical specifications.
• Plan, coordinate, and execute Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT).
• Evaluate equipment, systems, facilities, and process changes for validation impact and provide technical support for change controls.
• Author and review SOPs, validation procedures, protocols, technical reports, and supporting GMP documentation.
• Support technology transfer, equipment implementation, facility expansion, and new product introductions through qualification and validation activities.
• Troubleshoot validation deviations, investigations, and CAPAs while identifying root causes and implementing effective corrective actions.
• Perform validation risk assessments using Quality Risk Management (QRM) principles.
• Ensure validation activities remain compliant with applicable regulatory requirements, company procedures, and industry standards.
• Support internal audits, client audits, and regulatory inspections related to validation.
• Mentor junior validation personnel and provide technical guidance as required.
• Participate in continuous improvement initiatives to improve validation lifecycle management and operational efficiency.

Qualifications

• Bachelor's degree in Engineering, Pharmaceutical Sciences, Biology, Chemistry, Biotechnology, or another related scientific discipline.
• Minimum of four (4) years of validation experience within a GMP-regulated pharmaceutical, biotechnology, medical device, or CDMO environment.
• Experience supporting sterile pharmaceutical manufacturing operations is preferred.
• Working knowledge of equipment qualification, facility qualification, utility qualification, process validation, cleaning validation, sterilization validation, and computerized system validation.
• Working knowledge of applicable CGMP regulations, GxP principles, and industry standards including FDA, EU GMP (Annex 1 where applicable), ICH, ISPE, ASTM, GAMP 5, and applicable USP guidance.
• Experience supporting technology transfers, facility expansions, commissioning, and qualification activities is preferred.
• Experience supporting FDA, international regulatory authority, and client inspections is preferred.
• Experience supporting cleaning and sterilization validations including CIP, SIP, autoclave, VHP, etc.
• Ability to interpret engineering drawings, P&IDs, electrical schematics, specifications, and technical documentation.
• Strong technical writing, project management, communication, analytical, and problem-solving skills.
• Professional certifications related to validation, engineering, automation, or quality are desirable.

Equal Opportunity Employer

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person