Engineering & Electronics

Change Control Coordinator

  • Contract
  • Remote
  • Carlow
  • 41830935

The role:

PE Global is currently recruiting for a Change Control Coordinator on behalf of our client based in Carlow. This is an initial 11 month contract role.

 

Reporting to the Associate Director Technical Engineering (CPEG) as change control coordinator you will manage the change controls from initiation to closure, keeping track of all change controls for the group. The change controls will include but are not limited to: Process improvements, capital projects and Lean projects across multi-disciplined functions which may also require global and network support and collaboration

 

Responsibilities:

  • Understand and progress a change through the upfront business process Change Proposal Work Sheet (CPWS) and Value Chain Management Team (VCMT) process.
  • Change control SME for the group – keeping up to date with all updates
  • Process Change Controls on in Trackwise© Change Management Software
  • Progress change controls from initiation through to concurrence (approval) ensuring compliance to the site & global change control process (GCM Global Change Management).
  • Stay up-to-date with ‘OVERDUE MMD-GCM records’ & aging TR’s Reports to react accordingly and ensure metric compliance
  • Keep track of all change controls metrics for the group
  • Coordinating with the Project Engineer to manage the change control Work Stream from concurrence (approval) to closure.
  • Drive collaboration between groups within the Technical Engineering function proactively looking for synergies and innovative ways of doing work. Constantly assessing our systems and processes to see what improvement we can make to work smarter and more efficiently while all the time being compliant
  • Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities. Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance
  • Work collaboratively to drive a safe and compliant culture in Carlow. Collaborate with multiple partners (e.g. Company network groups, third parties, vendors, quality, donor sites, Supply chain, IPT) in achieving excellence in technical transfer programmes.
  • Manage and track any CAPA’s that are associated with the group ensuring they are tracked appropriately by all owners.
  • Assist with management of EHS documentation associated with projects

 

Qualifications, Skills & Experience:

  • Bachelor Degree or higher preferred; ideally in a Science, Engineering or Other Technical discipline
  • Considerable experience in a comparable role; would typically have experience operating as a senior professional and adding considerable value to the business
  • Would have engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in management of change controls.
  • Experience in leading through change would be an advantage
  • TrackWise© experience an advantage
  • Knowledge of regulatory/code requirements to Irish, European and International

Codes, Standards and Practices

  • Proficient understanding and experience of Sterile filling processes and equipment especially aseptic processing an advantage
  • Experience of executing and/or managing through equipment and process design and validation in a sterile environment an advantage
  • Good shipping/Filter/Cleaning validation knowledge required
  • Excellent report, standards, policy writing skills required
  • Proficiency in Microsoft Office and job-related computer applications required
  • Lean Six Sigma Methodology experience desired
  • Experience in audit preparation and execution desired
  • Have a proven record of project management of change in a commercial site

 

Interested candidates should submit an updated CV.

 

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

 

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***

 

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