Job Information
Amgen Maintenance Manager - Inspection & Packaging (Shift) in Dún Laoghaire, Ireland
This position will form part of a team of maintenance managers who work together to lead the Inspection and Packaging maintenance shifts within the Facilities and Engineering function and will report to the Day Maintenance Manager.
The Maintenance Manager provides support to the Maintenance team and Senior Maintenance Technicians on shift. Technical management of corrective and preventive maintenance on shift and technical support for the maintenance team.
Key Duties and Responsibilities:
Providing leadership and direction to the shift maintenance teams supporting the manufacturing processes, maintaining high levels of quality and safety in all operations.
To manage the execution of the maintenance plan through daily handover, coordination, technical and planning meetings with various plant stakeholders.
Operates as part of the Engineering/Manufacturing/Quality leadership team on the production floor, escalating and communicating effectively using agreed processes consistently to standardise the response to any unplanned events.
Ability and willingness to provide on shift cover for shift maintenance managers during period of planned absence.
Assigns work to technician team, actively managing the resources whilst managing the shifts. Supports the team in meeting standard daily, weekly, and monthly goals.
Ensures adherence to GxP & SOP requirements for tasks assigned and executed by the team with an ongoing focus on quality.
Support investigations into process deviations and robust CAPA execution/closure.
Maintains a high level of supervision and safety compliance during work execution and identifies areas for improvement with the team. Conducts safety walks and provides technical input into incidents and investigations.
Actively supports the team to manage system access, training, and qualification compliance. Supports the coordination of equipment access, training and vendor supported works across the shifts.
Assists in the delivery of the monthly maintenance plan across the production suites ensuring opportunities to access highly utilised equipment are coordinated and realised.
Proactive administration of work orders in the CCMS (Maximo), ensuring documentation is accurate and logged contemporaneously with minimal rework or backlog generation.
Aligns forecasted maintenance hours and resources with the planning teams. Refine plans at point of execution to balance priorities as part of a cross functional team.
Coordinates an effective response to emergencies and equipment breakdown by minimising maintenance downtime and executing corrective maintenance efficiently.
Ensures work completed each shift is documented and hand over communication, both written and verbal, is standardised, robust and comprehensive.
Identifies waste and works to remove plant bottlenecks and flow interrupters.
Provide technical support and coordination for engineering trials and equipment related project activities.
Basic Qualifications:
Bachelor’s degree in Engineering or equivalent qualification and/or experience.
Minimum of 5 years' experience in a GxP or other highly regulated manufacturing environment preferably with at least 2-3 years in a supervisory role.
Knowledge and Relevant Experience:
Working knowledge of pharmaceutical/biotech industries / aseptic processing and/or packaging operations.
Fundamental knowledge of applicable regulatory requirements (GxP & EHS)
Quality systems management (e.g., Non-Conformance, Change Control, CAPA)
Equipment troubleshooting and maintenance strategies and systems
Resource planning, scheduling and prioritisation
Knowledge of relevant computer systems and applications (e.g., Maximo, SAP, Learning Management System, Process Control Systems, Electronic Batch Records)
Continuous improvement tools and methodologies
Skills:
Independent, self-motivated, organized, able to multi-task in complex environments and skilled in communication and collaboration.
Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
Flexible with the ability to plan and adapt to situations as they arise as part of a team.
Ability to articulate and escalate issues professionally and efficiently.
Problem solving and logical mindset to navigate complex issues.