Senior Process Manager - Validation Engineering

About the Role

We are collaborating with a prestigious global healthcare manufacturing company to hire an experienced Senior Manager in Process Validation based in Dublin, Ireland. This leadership role involves formulating and executing validation strategies across a worldwide manufacturing network, ensuring strict adherence to GMP and relevant industry standards for equipment, facilities, utilities, automated systems, manufacturing processes, and cleaning validation.

Key Responsibilities

• Direct a global Validation Engineering team by setting strategic goals, managing planning, and overseeing execution across several locations.
• Create and implement validation approaches consistent with global technical operations.
• Supervise all validation activities, including equipment, facilities, utilities, automated systems, production processes, and cleaning procedures.
• Review and approve Validation Master Plans, protocols, and validation documents such as Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT).
• Promote standardization and synchronization of validation methods across international sites.
• Advocate for risk-based and science-oriented validation methodologies.
• Maintain compliance through scheduled evaluations and governance of validated systems.
• Facilitate technology transfers, launch of new products, and process integrations.
• Collaborate with Quality, Engineering, Manufacturing, and other cross-functional teams.
• Mentor, lead, and grow a high-performing team dedicated to validation engineering.
• Support initiatives focused on continuous improvement and Lean Sigma methodologies.

Candidate Profile

The ideal candidate has a strong background in validation leadership with sound technical knowledge of regulated manufacturing settings.

Mandatory Qualifications

• A degree in Engineering, Computer Science, or a related field.
• At least 10 years of experience in validation engineering within a current Good Manufacturing Practice (cGMP) setting.
• Over 10 years of experience in high-volume pharmaceutical or medical device manufacturing.
• Evidence of successful people management skills.
• Proficient understanding of EU GMP, ISO 13485 standards, and FDA CFR Part 820 regulations.
• Hands-on experience in IQ, OQ, PQ, and managing the complete validation lifecycle.
• Excellent communication skills and ability to manage multiple stakeholders effectively.
• Capability to operate in a complex matrix and across multiple sites.
• Willingness to undertake travel up to approximately 5% of the time.

Preferred Skills

• Experience in plastics manufacturing.
• Knowledge of Computer System Validation (CSV).
• Background in Lean and Continuous Improvement practices.
• Exposure to electronic validation systems.

Additional Information

This opportunity allows you to lead a technical team and influence validation approaches at a global scale within the healthcare manufacturing sector, contributing to the production of high-quality products that advance health outcomes.

Data protection measures are strictly enforced in compliance with legal obligations. Personal information provided in the application process will not be shared with any company without explicit consent and cross-border data transfers are managed under appropriate regulatory frameworks.