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Inverin, County Galway, Ireland, Ireland
Onsite
Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.
We have been included on number of award lists that demonstrate the impact we are making.
Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.
For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.
The Role & What You Will Be Doing
Every day, we rise to the challenge to make a difference and here’s how the Regulatory Affairs Specialist role will make an impact:
Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.
For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.
The Role & What You Will Be Doing
The Senior Engineering Manager is a senior leadership role responsible for developing and executing maintenance strategies for equipment, facilities, and utility systems, ensuring alignment with organisational goals, regulatory requirements, and industry standards while maintaining high levels of safety, quality, compliance, and efficiency.
The role provides technical leadership across site infrastructure, including critical utilities such as HVAC, water systems, power distribution, and cleanrooms, with accountability for reliability, performance, and audit readiness.
A key focus is driving sitewide equipment reliability through TPM & RCM methodologies, implementing preventative and predictive maintenance programmes, continuous improvement initiatives, and cost-effective, sustainable solutions.
The position ensures full compliance with GMP, EHS, and regulatory standards, supporting
Key Responsibilities
Every day, we rise to the challenge to make a difference and here’s how the Senior Manager Sterility Assurance will make an impact:
Lead, mentor and develop multidisciplinary maintenance, engineering and facilities teams, fostering accountability, engagement and high performance.
Develop and execute multi‑year engineering and capital investment strategies to support capacity, compliance and business growth.
Act as a senior site leader, contributing to site governance, risk management and operational decision‑making.
Drive engineering reliability, asset lifecycle management, preventive maintenance and technical problem‑solving.
Oversee process development, technology transfer, and automation initiatives to enhance manufacturing efficiency.
Manage annual and multi‑year capital budgets, ensuring cost control, governance and return on investment.
Identify and mitigate risks to Facility operations.
Partner closely with Manufacturing, Quality, Supply Chain and MS&T to align on operational needs.
Ensure compliance with HPRA, FDA, GMP, cGMP, ISO, and other global regulatory standards.
Oversee the development and maintenance validation and qualification protocols (IQ, OQ, PQ) for pharmaceutical manufacturing
Partner with Quality, EHS and Regulatory teams to ensure product safety and compliance
Drive sustainability initiatives, reducing waste and improving energy efficiency in operations
Develop, Implement, and promote a Reliability Centered Maintenance (RCM) strategy using Failure Mode Effects and Criticality Analysis (FMECA/FMEA) assessments in conjunction with department management, the maintenance planner / scheduler and the Production department utilizing tools such as Trend’s analysis & Control charts & Data review
Perform other duties as assigned
About Your Skills & Experience
The successful candidate will have the following qualifications, skills, and experiences:
Bachelor's or Master’s in Engineering (Mechanical, Chemical, Biomedical, Industrial, or related field)
Minimum ten years of plant engineering leadership experience in the pharmaceutical industry with a strong understanding of sterile drug manufacture and cGMP requirements
PMP, Six Sigma Black Belt, Lean Manufacturing certified preferred
Strong understanding of Annex I, US, and EMA GMP regulations, with practical experience in regulatory audits.
Aseptic Process Expertise, proven experience in contamination control strategies, including cleaning and disinfection validation.
Strong technical knowledge of the operation, monitoring and maintenance of pharmaceutical manufacturing equipment and facilities. This includes environmental control equipment and other utilities
Demonstrated ability to plan, design and manage significant capital expansion projects
Knowledge of process control techniques, maintenance procedures and safe work practices along with a working knowledge of engineering codes and standards
Experience with regulatory & documentation requirements that relate to facilities upgrades, qualifications and equipment purchases, installations, qualifications and validations
Strong problem solving and critical thinking skills
At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.
Benefits at Viatris
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive salary:
Excellent career progression opportunities
Work-life balance initiatives
Bonus scheme
Health insurance
Pension
Diversity & Inclusion at Viatris
At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion
Sustainability at Viatris
Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer.