Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
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Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
The main purpose of the Maintenance Manager is to provide leadership to the maintenance department overseeing equipment maintenance, ensuring regulatory compliance, managing maintenance staff, implementing improvement strategies, controlling costs, and collaborating with other departments to ensure the reliability, compliance, and efficiency of pharmaceutical packaging operations within the PCI Dublin sites.
Key Responsibilities:
• Develop and implement a comprehensive maintenance strategy to ensure the reliable operation of all packaging equipment across the PCI Dublin sites.
• Lead, mentor, and manage maintenance associate managers and supervisors, providing guidance and support to ensure efficient and effective execution of maintenance activities.
• Establish and maintain a preventive maintenance program to minimize downtime, reduce equipment failures, and ensure compliance with regulatory requirements.
• Collaborate with other departments, including operations, quality assurance, project engineering and validation, to prioritize maintenance activities and minimize disruptions to production schedules.
• Oversee the planning and execution of equipment installations, upgrades, and modifications, ensuring adherence to safety regulations and cGMP guidelines.
• Utilize maintenance management software and paper-based systems to track equipment performance, maintenance activities, and spare parts inventory, and generate reports to monitor KPIs and identify areas for improvement.
• Develop and manage the maintenance budget, including forecasting, cost control, and procurement of spare parts and maintenance supplies.
• Ensure compliance with all applicable regulatory requirements, including FDA, EMA, HPRA and other global regulatory agencies, as well as environmental, health, and safety regulations.
• Work with the CI manager to drive continuous improvement initiatives to enhance equipment reliability, minimize energy consumption, and optimize maintenance processes.
• Work with the reliability Engineer to ensure equipment changeovers are right first time.
• Contribute to the development and implementation of training programs for maintenance staff to enhance technical skills, safety awareness, and compliance with industry best practices.
• Manage the Maintenance department’s safety programme and drive the Site’s vision on zero recordable accidents and help maintain a safe working environment for staff.
• Coaching, mentoring and development of members of the Maintenance department to include performance review and appraisal.
• Support the Site Commercial Business Unit and align daily with Site management team to ensure weekly schedules are achieved on time in full (OTIF).
• Drive a Right First-Time (RFT) culture throughout the Maintenance Department to deliver a zero-defect performance rate.
• Lead the Maintenance team in delivering GDP (Good Documentation Practice) via principles of the ALCOA (Attributable, legible, Contemporaneous, Original and Accurate) system of integrity.
• Raise and own Change Controls, CAPA , Events and Deviations through the use of Master Control ( QMS )
• Manage the team’s training schedule in compliance with Site policies and procedures.
• Work with the Procurement team to identify preferred suppliers/vendors for the Maintenance department and associated equipment sets.
• Create and sustain a working environment that promotes the PCI Values and Behaviours.
• To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities.
• Driving and embedding a ‘One PCI’ culture, brand and message.
Knowledge / Skills & Experience
Essential:
• Bachelor’s or associate degree or Diploma / Certificate in Engineering / Science (e.g. business, logistics, systems engineering, supply chain management or similar). May substitute experience in lieu of educational requirements or experience
• 5-10 years’ experience working in Engineering / Maintenance
• 5-10 years in a supervisory / people management role. • Proven track record of showing how results were delivered through management/leadership of others
• Proven track record of showing how results were delivered through management/leadership of others
• Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
• Ability to manage multiple tasks and set priorities.
• Problem Solving and Troubleshooting skills. The successful candidate should display a dynamic and proactive approach to manage problems.
• Self-motivated with a results driven approach.
• Flexibility to work across different shifts on request in line with business needs.
• Adaptable and ability to work collaboratively.
• Proficient in Microsoft Office products (incl. Excel, PowerPoint, Word, etc.) Desirable:
• Experience in a GMP or Regulated Environment.
• Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements
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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.