Senior Principal Validation Engineer

Role Overview: We are seeking a Senior Principal Validation Engineer to join a dynamic team undergoing a facility expansion. This critical role will support the team's expansion efforts and other key projects at this site.

Key Responsibilities:

• Project Management: Oversee validation activities, review change controls, maintain validated equipment, and update validation documents.
• Department Collaboration: Ensure timely completion of risk assessments and validation activities for new components, equipment, systems, and utilities.
• Product Introduction Support: Manage equipment re-qualification schedules and ensure plant readiness post-shutdowns.
• Engineering and Facilities Coordination: Ensure proper system installation and operation, providing technical support for validated systems.
• Protocol Development: Develop and execute protocols, completing reports for equipment, processes, utilities, and re-validations.
• SOP Creation: Write Standard Operating Procedures (SOPs) for new processes and equipment.
• Project Assistance: Support engineers, calibrations, and validations on ongoing projects.
• Audit Support: Provide and present data for internal and external audits.
• Compliance Assurance: Follow current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDPs).
• Document Review: Prepare validation protocols, final reports, and summaries for equipment release.
• Validation Liaison: Communicate with customers or regulatory agencies during facility audits.

Key Qualifications:

• Bachelor's degree in Science, Engineering, or a relevant field (Advanced degree preferred).
• Over 10 years of validation experience in the biopharmaceutical industry.
• Strong experience in validation of equipment, facilities, and utilities.
• In-depth knowledge of FDA and EU regulations for pharmaceutical and validation requirements.
• Experience in aseptic/sterile manufacturing facilities with a strong understanding of the sterile manufacturing process.
• Experience supporting or leading expansion projects is highly preferred.
• Familiarity with standard filling line validation.