Job Description:

We have an exciting opportunity for an API Operations Manager (Days) for our site in Ballydine, Co. Tipperary, to support the day-to-day operations of and deliver on the project milestones. You will support the operationalisation of the facility to ensure that facility can reliably achieve production, quality and continuous improvement targets. Specifically supporting the CQV effort. As a member of the API Integrated Process Team (IPT), you will lead a small production team, own performance metrics, drive Operational Excellence, ensure rigorous cGMP and safety compliance, and provide operational & technical leadership for processing, process transfers and capital projects. You will also act as a reserve shift manager, stepping in to support shift operations when needed to maintain continuity.

Role Profile

• Own and report production performance metrics (inventory, cost, cycle time, customer service) and develop action plans to close gaps.
• Identify, prioritise, and champion Operational Excellence projects using Lean tools (VSM, 5S, waste elimination, variability reduction).
• Drive CQV on BACE project to meet IPT and capital project targets.
• Contribute to daily, weekly, and monthly IPT accountability processes; provide input and escalate issues.
• Ensure adequate, competent resources are available and deployed to meet production commitments.
• Manage events and deviations that impact targets and lead resolution activities across functions.
• Ensure high-containment processing operations comply with cGMP, environmental, labour, and industrial health & safety regulations.
• Act as a sub-system owner within Quality/GMP systems and report trends (deviations, incidents, audit findings, regulatory issues).
• Serve as a member of the site Emergency Control Centre during emergencies.
• Maintain and promote best practice for high-potency containment, PPE, decontamination, and engineering controls.
• Deliver performance within profit plans and support cost control initiatives.
• Lead, coach, and develop production personnel; set expectations, deliver feedback, and assess performance.
• Embed Lean/MPS behaviours and sponsor continuous improvement at team level.
• Ensure adherence to union agreements and act as primary production contact for SIPTU matters; participate in plant negotiations as required.
• Provide subject matter expertise in unit operations, MES and DeltaV across API.
• Support process transfers and new product introductions for high-potent compounds, including Process Hazard Assessments (PHA), process fit reviews, and technology transfer activities.
• Act as the primary operations representative for the department on cross-functional capital project teams.
• Review and contribute to project design documents (equipment, facilities, utilities) with high-containment requirements in mind.
• Develop operating procedures, SOPs, and start-up documentation in conjunction with operations.
• Lead facility qualification and start-up activities for high-containment assets, including documentation generation, execution, issue resolution, and closeout.

Your profile

• Honours degree in Engineering, Science or Business Administration (or equivalent).
• Minimum 2 years’ line management experience in a production environment, with direct people leadership.
• Deep technical experience in API, MES, and/or DeltaV operations.
• Proven experience with Operational Excellence/Lean tools (VSM, 5S etc.).
• Strong knowledge of cGMP, quality systems, H&S and environmental regulations.
• Experience in process transfer, PHA, technology transfer and capital project delivery.
• Excellent planning, analytical problem-solving, communication and stakeholder management skills.
• Leadership and people development
• Results orientation and continuous improvement mindset
• Industrial health, safety, and high-containment expertise
• Project and budget management
• Technical judgment, decision making and cross-functional collaboration.

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:

Automation, Automation, Capital Projects, CNC Manufacturing, Corrective Action Management, Cross-Functional Collaboration, Cross-Functional Communications, Driving Continuous Improvement, Environmental Regulations, Environmental Safety, Fabrication Processes, GMP Operations, Lean Management, Machinery Operation, Manufacturing Operations, MES Integration, Operational Excellence, People Leadership, People Performance Management, Production Efficiencies, Production Quality Control, Production Scheduling, Raw Material Specifications, Regulatory Issues, Reliability Engineering {+ 3 more}

Preferred Skills:

Current Employees apply HERE:

Current Contingent Workers apply HERE:

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Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

02/27/2026

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