Engineering Systems and Planning Coordinator
Full Job Description
Reporting to the Building Services and Utilities Manager, this role has responsibility for the support, implementation and qualification of a GMP compliant Computerised Maintenance Management System (CMMS) in the Eisai Knowledge Centre (EKC) facility at Hatfield.
Ensuring that the CMMS is used effectively to maintain GMP compliance, data integrity and planning of all engineering activities in line with production schedules and other EKC functions to assure key dates are not missed.
“To ensure that operations carried out within your area of responsibility are carried out in accordance with the requirements of the Eisai Quality System, GMP Guidelines and Industry Standards.”
- Day to day management of the Engineering Systems and Planning Function
- Generation, closure and retention of all maintenance records.
- Deliver, upgrade and qualify the CMMS as required.
- Accountable for the quality and accuracy of data on the CMMS system
- Responsible for the control of engineering documentation
- Long term (> 1 month) forecast planning of engineering activities in conjunction with the applicable EKC and engineering groups.
- Represent the department during GMP and EHS audits by external regulatory bodies.
- Producing monthly KPI’s based on performance and SLA’s
- Provide CMMS training and training material
- Work with others to ensure engineering data (asset, maintenance, failure etc.)is gathered, analysed, acted upon and stored as a key project deliverable
- Proposing changes to maintenance plans based on the above engineering and performance data
- Managing the delivery, auditing and upkeep of site engineering standards
- Providing CMMS helpdesk support
In the case of GMP systems:
- Ensure GMP compliance and self-inspections of systems used.
- Ensure criticality and source of spare parts are known and procured accordingly.
- The quality and completeness of GMP documentation and data on the controlling maintenance management system.
- Undertaking Change Controls, Deviation Investigations, Corrective Action and Preventative Action (CAPA) management, root cause analysis (RCA) and continuous improvement activities.
Skills and Competencies:
Good understanding of GMP.
Accomplished GMP/EHS auditee.
Excellent communication and interpersonal skills.
Be able to work effectively with in house and external/sub-contracted engineering resources
Be able to work unsupervised and meet set deadlines.
Arrange and chair meetings to provide updates and tracking
Ability to work under pressure, prioritise and multitask.
Passion for “right-first-time” processes and a determination to understand breakdown/failure root cause and prevent reoccurrence.
Ability to identify opportunities for process & operational improvements and implement appropriate project changes to deliver these benefits.
Planning, organising and coordinating skills.
Ability to prioritise and manage multiple tasks and projects.
MS Office suite (Excel, Word, Power-point).
Demonstrated relevant experience in the Pharmaceutical industry.
Demonstrable experience of managing a CMMS.
People management including contractors and outsourced functions.
Familiarity of GMP and EHS requirements of engineering systems.
Demonstrable experience of managing Engineering plans and records
Maintain the CMMS through ensuring the accuracy of GMP quality critical data. Help continue to maintain the delivery and upkeep of the site engineering standards through maintenance planning, scheduling and report matrix.
HNC/HND or higher in engineering related field or equivalent.