Sr. Validation Engineer

About the Role

The Equipment Validation Engineer III plays a key role in supporting a sterile pharmaceutical manufacturing facility through the qualification and lifecycle management of manufacturing equipment, utilities, and associated systems. This position leads equipment qualification and change-based revalidation activities, supports manufacturing investigations, and collaborates with Operations, Engineering, Maintenance, Quality, and Regulatory functions to ensure compliance with cGMP requirements. The successful candidate will serve as a technical lead for validation projects of moderate to high complexity, providing expertise in risk-based validation strategies, equipment qualification, and continuous process improvement. This role offers significant exposure to new equipment implementation, regulatory inspections, and cross-functional project teams supporting commercial pharmaceutical manufacturing.

Why Join Our Team?

• Opportunity to lead high-impact validation projects in a sterile pharmaceutical manufacturing environment.
• Exposure to equipment implementation, capital projects, and advanced manufacturing technologies.
• Collaborative cross-functional environment with Operations, Engineering, Quality, and Regulatory organizations.
• Opportunity to mentor developing engineers and influence site validation strategy.
• Direct contribution to the manufacture of critical pharmaceutical products that impact patient health.

Responsibilities

Equipment Qualification & Validation

• Lead equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new and existing manufacturing equipment.
• Perform change assessments and lead requalification activities in support of equipment modifications, process changes, and lifecycle management.
• Author, execute, and review validation impact assessments, protocols, test scripts, summary reports, periodic review reports and supporting documentation.
• Ensure validation activities are executed in accordance with applicable cGMP regulations, company procedures, and industry best practices.

Project Leadership

• Serve as validation lead for capital projects, equipment implementation efforts, and cross-functional initiatives.
• Partner with Engineering during equipment design, installation, commissioning, startup, and qualification phases.
• Coordinate qualification activities across Operations, Quality Control, Quality Assurance, Engineering, Maintenance, and Manufacturing Science teams.
• Manage multiple validation projects simultaneously while maintaining project timelines and priorities.

Technical Support & Continuous Improvement

• Support manufacturing investigations, deviation assessments, root cause analyses, and CAPA implementation activities related to validated systems.
• Participate in risk assessments and develop scientifically sound validation approaches.
• Identify opportunities to improve validation processes, documentation practices, and operational efficiency.
• Provide technical guidance and support for equipment lifecycle management activities.

Compliance & Regulatory Support

• Maintain validation documentation in a state of audit readiness.
• Support internal audits, client/customer audits, and regulatory inspections, including FDA and other global regulatory agencies.
• Contribute validation documentation and