Sr. Manager, Validation Engineer

Responsibilities

• Provide strategic and technical leadership for validation activities supporting manufacturing processes, equipment, utilities, and computerized systems within a regulated pharmaceutical CDMO environment.
• Lead a team of Validation Engineers and ensure validation activities are executed using a risk-based, science-driven approach that supports operational readiness, inspection readiness, customer expectations, and business objectives.
• Ensure validation activities comply with FDA, EMA, ICH, cGMP, and other applicable regulatory requirements and industry standards.
• Support and lead process improvement initiatives focused on validation lifecycle execution, documentation efficiency, risk management, and operational excellence.
• Participate in inspection readiness activities and support regulatory agency interactions as required.
• Serve as a technical liaison between Validation, Quality, Manufacturing, Engineering, Regulatory Affairs, Project Management, and external customers.
• Partner with internal and external stakeholders to ensure validation deliverables support business priorities, operational readiness, and successful project execution.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related scientific discipline; equivalent experience may be considered.
• Minimum of 10 years of validation experience within the pharmaceutical, biotechnology, medical device, or related regulated industry.
• Minimum of 3 years of supervisory experience or demonstrated experience leading validation teams.
• Strong knowledge of cGMP regulations, validation lifecycle principles, and global regulatory requirements including FDA, EMA, and ICH guidelines.
• Experience with equipment, process, utility, and computerized system validation (CSV).
• Demonstrated expertise in risk-based validation approaches, investigations, CAPAs, change management, and quality systems.
• Strong communication skills with the ability to effectively engage customers, regulatory agencies, and cross-functional teams.
• Proven leadership, organizational, project management, and problem-solving skills with the ability to manage multiple priorities in a fast-paced environment.

Preferred Qualifications

• Experience working within a CDMO environment supporting multiple customers and concurrent projects.
• Six Sigma Green Belt certification or equivalent continuous improvement experience.
• Experience supporting customer audits, regulatory inspections, and validation strategy discussions with external stakeholders.