Director of Engineering

About the Role

The Director of Engineering will oversee all daily manufacturing operations of pharmaceutical products at the Viatris sites in Inverin and Casla, Galway, Ireland. As part of the senior management team, the role involves shaping company culture, corporate social responsibility, strategic planning, and securing the long-term sustainability of the site. This position carries significant responsibility in decision-making, ensuring the reliability of the supply chain, meeting quality standards, maintaining satisfactory inventory, and achieving budget targets. Long-term capacity planning will also be a key responsibility.

Key Responsibilities

• Develop and execute engineering strategies that align with corporate objectives.
• Manage extensive capital projects including new constructions, expansions, and equipment upgrades, overseeing Capital Expenditure budgets and external contractors or consultants.
• Lead initiatives related to process development, technology transfers, and automation to boost manufacturing efficiency.
• Ensure compliance with regulatory frameworks including HPRA, FDA, GMP, cGMP, ISO, and international standards.
• Oversee development and upkeep of validation and qualification protocols such as IQ, OQ, and PQ for pharmaceutical manufacturing.
• Collaborate closely with Quality, Environmental Health & Safety, and Regulatory departments to guarantee product safety and conformity.
• Work with Operational Excellence teams to optimize critical systems like HVAC, cleanrooms, water treatment, and aseptic processing to sustain sterile manufacturing environments.
• Champion sustainability programs aimed at reducing waste and improving energy efficiency across operations.
• Lead diverse multi-disciplinary engineering teams across multiple sites and global operations.
• Foster employee growth through mentoring, training initiatives, and succession planning.
• Manage engineering budgets, ensuring stringent cost controls and positive returns on capital investments.
• Identify, analyze, and mitigate risks related to production, supply chain, and facilities management.
• Design and implement a Reliability Centered Maintenance (RCM) strategy using Failure Mode Effect and Criticality Analysis (FMECA/FMEA), partnering with department leadership and utilizing tools such as trend analysis, control charts, and data reviews.

Qualifications and Experience

• A Bachelor’s or Master’s degree in Engineering fields such as Mechanical, Chemical, Biomedical, or Industrial Engineering.
• Preferred certifications include PMP, Six Sigma Black Belt, and Lean Manufacturing.
• At least 15 years of experience in senior leadership roles within sterile manufacturing environments.
• Comprehensive knowledge of regulatory requirements including Annex I, US FDA, and EMA GMP regulations, complemented by direct experience in regulatory audits.
• Expertise in aseptic processes and contamination control strategies including cleaning and disinfection validation.
• Proven leadership skills with aptitude in mentoring and team development.
• Strong capabilities in risk assessment and problem-solving.
• Excellent communication skills with the ability to effectively collaborate across different departments to ensure compliance and drive process enhancements.