System Handover Coordinator

Ref: 00817

SYSTEM HANDOVER COORDINATOR

A new and exciting contract opportunity now exist at our clients Dundalk Site for a Change Control Coordinator across the Utilities and Engineering Departments. Reporting to the Associate Director of Engineering as change control coordinator you will manage the change controls from initiation to closure, keeping track of all change controls for the group.

PURPOSE:

The Change Control Coordinator will also include coordination between M&E and associated trades contractor companies and engineering services suppliers engaged on Process Utilities improvement and capital projects across multi-disciplined functions. The selected candidate will typically have prior related change control experience; ideally in manufacturing, preferably GMP Setting with engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in change control management and services coordination.

The change control coordinator will work in conjunction with Project engineers to support manufacturing operations to remain operational, continuously improve and innovate. With our clients extensive range of facilities and environments, this is an excellent opportunity to work across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

DUTIES:

The person will be responsible for:
 Change Control Coordinator for the group – keeping up to date with all updates
 Process Change Controls on Trackwise Change Management Software
 Progressing change controls from initiation through to approval ensuring compliance.
 Stay up-to-date with reports to react accordingly and ensure metric compliance
 Keeping track of all change controls metrics for the group
 Partnering with colleague’s cross-functionally to ensure change controls are progressed in advance of project start.
 Coordinating with Project Engineer to manage change control Work Stream from approval to closure.
 Driving collaboration between groups within the Engineering function proactively looking for synergies and innovative ways of doing work.
 Constantly assessing systems and processes to see what improvements can be made to work smarter and more efficiently while all the time being compliant
 Complying with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities.
 Compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance
 Working collaboratively to drive a safe and compliant culture.
 Collaborating with multiple partners e.g. company network groups, third parties, vendors, quality, Supply chain.
 Assisting with management of EHS documentation associated with projects

EDUCATION:

 Bachelor Degree Diploma; ideally in a Science, Engineering or Technical discipline. Trades background ideal

EXPERIENCE:

 Experience of working in a Trades /Contractor Construction Project Environment
 Experience in a similar role /pharmaceutical multidisciplinary projects.
 Engineering and/or CQV experience in a sterile manufacturing environment
 Excellent Coordination/ Site Communication skills
 Proven track record in management of change controls.
 Experience in leading through change would be an advantage

TECHNICAL COMPETENCIES:

 TrackWise / Excel experience an advantage
 Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
 Proficient understanding / experience of Sterile processes and equipment. Aseptic processing an advantage
 Proficiency in Microsoft Office and job-related computer applications required
 Have a proven record of project management of change in a commercial site
 Having a strong safety ethos

BUSINESS COMPETENCIES :

 Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external suppliers and stakeholders in a team orientated manner
 Understand the specific responsibilities of all Dundalk functions as they relate to WuXi Engineering /Utilities department as well as associated groups (QA, Operations, CQV etc)
 Excellent people management skills
 Strong influence skills
 Demonstrate analytical and systematic problem-solving skills
 Effective time management and multi-tasking skills
 Trouble shooting skills
 Goal/results orientated
 Excellent attention to detail
 Self-motivated
 Flexible approach
 Strong change management skills
 Effective conflict resolution skills
 Negotiation skills
 Strategy planning and development
 Risk management skills
 Excellent facilitation and assessment skills