API Maintenance Lead

Job Description

We have an exciting opportunity for an API Maintenance Lead (Assoc. Dir) for our site in Ballydine, Co. Tipperary, with responsibility for all maintenance related activities for the API IPT and its equipment. You will lead a high performing maintenance team that is focused on talent development, capability build and growth mindsets. The successful candidate will ensure effective maintenance planning & scheduling to deliver high asset availability, meet compliance expectations and effective cost management.

Ballydine is the primary Drug Substance commercialisation hub within the network, where new processes are scaled and transitioned to commercial manufacture. The site supports clinical and commercial API supply and the transfer of processes and technologies across internal manufacturing sites and external partners.

Role Profile

• Planning and scheduling of all planned maintenance work activities (PM & CM) for facilities and equipment to achieve optimum levels of maintenance planning.
• Execution and close-out of all maintenance activities
• PM program development / optimisation for equipment.
• Investigation and closure of all PM deviations and equipment related deviations.
• Management of Engineering expense expenditure (routine & non-routine).
• Maintenance input into the site capital plan.
• Maintenance interface for all API IPT projects executed by the Site Projects Group (priority, scope, design/safety reviews, acceptance etc.).
• Maintenance input into shutdown planning process and subsequent coordination.
• Subject matter expertise on assigned equipment systems.
• Accountable for delivering high asset uptime through effective maintenance while also meeting PM/Calibration compliance requirements. Reports Engineering metrics and any action plans to address gaps.
• Working with the Reliability and Systems Lead drive continuous improvement through Model Area and digital solutions. Leverage MPS tools i.e. Model Area, Kata, 8 step problem solving & 5S.
• Responsible for ensuring that there are sufficient and effective resources available from within the group to meet business needs and is accountable for managing maintenance labour cost and repairs & spares spend.
• Accountable for ensuring that API asset management is performed in compliance with cGMP, Environmental, Labour, Industrial Health, and Safety regulations. The API Maintenance Lead is the topic owner for PM/Calibration.
• Responsible for ensuring all compliance related deviations are investigated and addressed in a timely manner.
• Prepares the Maintenance budget to support the API IPT. Monitors performance against budget targets and manages performance within profit plan. Responsible for the financial governance of Maintenance executed capital projects.
• Member of the Engineering Leadership Team to provide governance of the overall site Engineering Standards. Undertakes other activities, as directed by the Engineering Lead (e.g. site cross-functional teams etc).

Your profile

• Honours Degree in Engineering, Science, or equivalent post trade qualification & experience
• Broad Multi-Functional Experience
• Minimum 5 years’ experience in an engineering or maintenance environment
• Demonstrated knowledge of Operational Excellence & Asset Reliability Principles
• Good knowledge of Safety & Environmental legislation
• Strong Unit Operation and Plant Equipment knowledge

Leadership & Organisation Skills

• Focused on diversity and inclusion.
• Fosters a growth mindset.
• Focused on capability build i.e. MPS & technical.
• Fosters Teamwork & Collaboration
• Results-Oriented
• Excellent communication skills, both written and oral
• Demonstrated ability in Planning and Scheduling
• Structured problem solving
• Focused on customer service
• Conflict resolution
• Judgement and Decision Making
• Promotes good Work/Life balance.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. We are proud to be a company that embraces the value of bringing talented and committed people together. The fastest way to breakthrough innovation is when ideas come together in an inclusive environment.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.

Required Skills:

Capital Projects, Capital Projects, Cost Management, Cross-Cultural Awareness, Driving Continuous Improvement, Engineering Leadership, Engineering Principle, Engineering Standards, Estimation and Planning, Facilities Construction, GMP Operations, Health Safety Regulations, Interpersonal Relationships, Maintenance Management, Maintenance Planning, Maintenance Planning Software, Manufacturing Quality Control, Manufacturing Scale-Up, Mentoring Staff, People Leadership, Regulatory Issues, Talent Development, Talent Management, Teamwork, Technical Calculations {+ 2 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

07/16/2026

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