MES PROJECT MANAGER

My client requires an experienced MES Project Manager to join their project.

The MES IM Project Manager will serve as an integral member of the MES Program Team and the IM PMO. This position will have a significant role in the delivery of the MES Program, mainly responsible for coordination of all IM related activities in line with the overall project plan, from design through implementation.

The candidate will be able to demonstrate a proven track record of leading projects and influencing others, with excellent knowledge of Project management & IT Processes, strategic and tactical thinking abilities and a convincing communicator with strong interpersonal skills. The successful candidate will support and assist the IM PMO in delivery of IM elements of the MES program, achieving objectives within agreed time, cost and performance criteria.

RESPONSIBILITIES

·Single point of contact from the IM team on the MES Program.

·Coordinate IT related activities throughout the project life cycle to ensure that projects goals, budget and schedules are met.

·Manage spend, forecasting to financial close-out ensuring a continual focus on cost awareness.

·Work with project sponsor and stakeholders to manage scope, goals, deliverables, resource management, risks and issue management, budget and timeline.

·Ensure that IM scope is delivered to meet customer expectations and in line with IM standards

·Monitor progress of project milestones with all team members and provide status reports. Ensure that adequate communication plans are in place and delivered to ensure that all project stakeholders are informed and consulted on key project activities, progress and decisions.

·Develop and maintain appropriate electronic and paper documentation & filing systems to ensure that all project documents are filed during project execution and safely archived following project completion.

·Ensures that good Project management practices are utilised and aligned with customer's needs from requirements gathering, through design and execution.

·Manage project changes and ensure all are captured, documented and assessed.

·Generate IT change controls and drive their closure in a timely manner

·Responsibility for direct supervision of vendor engineers and contractors as required.

·Uses knowledge and expertise to challenge/question and coach/mentor others to do the same.

·Considers global/site implications for decisions made and actions taken.

·Promotes a safety and quality compliant culture across site.

·Uses cost-benefit thinking to set priorities.

·Analyses tasks to identify efficiencies and ensure efforts are focused on business critical and business improvement activities.

EDUCATION AND EXPERIENCE

5+ years' experience working as a Project Manager in a Global Bio-Pharmaceutical or equivalent type industry.

·5+ years technology or information systems experience

·Project Management Certification in PMP, Prince 2 or equivalent preferred.

·Experience/Knowledge in ERP, LIMS, EDMS, QMS, MES (PAS-X).

·Proficiency with MS Office applications (Word, Excel, Visio, Access, Project, Powerpoint).

·Strong knowledge of business processes across manufacturing, supply chain & quality

·Experience with Computer Systems Validation preferred

·Knowledge of 21 CFR Part 11 and EU Annex 11 regulations preferred

·Independent problems solving skills

·Experience implementing business improvements through more effective use of Enterprise Applications and related software

·Very strong interpersonal and communication skills.

·Yellow/Green Belt in Lean Six Sigma

·Demonstrated experience in leading projects from Design to Qualification.

Skills & Experience Required

·Good verbal and written communication skills.

·Good organizational skills.

·Must have good interpersonal skills. Position will involve a lot of interdepartmental interaction and coordination.

·Must possess a thorough understanding of GxP, in addition to FDA and International requirements for computer validation and Part 11/Annex 11 requirements.

·Must possess a thorough understanding of current industry guidance, including GAMP 5

·Must have direct experience with computer validation and determining computer validation approach, including enterprise platforms systems as well as custom software projects.

Please forward all cv’s to alan@lcaconsulting.ie