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Ruth Holland
Life Science

01 507 9255
[email protected]
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Process Owner - Packaging

Reference:/RH/AWNY-240112 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Packaging Analyst

Process Owner – Packaging required for a contract role with a Dublin based Biopharmaceutical facility.

Role Summary:
This position will report to the Sr. Manager Manufacturing - Packaging. The Process Owner provides a key interface between the shift operations teams and day based cross functional support. The Process Owner will provide key timely front-line operations support to the packaging process on all activities.
Working knowledge of equipment from various vendors would also be advantageous, including experience in packaging systems and processes.

The Ideal candidate will have:

  • Experience working in a manufacturing role and have a working knowledge of packaging equipment from vendors such as Uhlmann, Dividella, Neri, Sortimat and Pester.
  • Have a commitment to continuous improvement by embracing lean principles to increase the efficiency at which the department operates.
  • Be an effective problem solver using appropriate problem-solving tools/techniques who is capable of leading complex investigations and driving countermeasures through to closure to prevent re-occurrence.
  • Ability to work on own initiative to pro-actively identify and complete process improvements
  • Hands on experience facilitating problem solving and root cause investigations in a biotechnology environment
  • Strong project management skills with ability to multi-task and function in a dynamic environment
  • Excellent communication skills, drive, and sense of urgency
  • Demonstrated ability to forge and maintain strong relationships within other functional areas
  • Ability to recommend, judge, and make good decisions in complex situations
  • Ability to tactfully and effectively negotiate and influence

Essential Duties and Responsibilities may include, but are not limited to, the following:
  • Supports Packaging Operations Team and provides real time action on any process or equipment document updates in line with business objectives and scheduling demand.
  • Reviews packaging batch documentation (both paper and electronic) in a RFT manner to support timely release to support shipping and disposition cycle time (DCT) commitments.
  • Takes a proactive approach to safety, quality and compliance and actively seeks opportunities to prevent adverse events from occurring.
  • Contribute to and assist with Corporate, FDA, HPRA and other regulatory bodies during GMP audits.
  • Utilises significant subject matter expertise to support projects relating to improvements and investigation within their area. This relates to documentation support to investigations, CAPA’s, change controls, training, improvement projects and Audit support.

Education and Experience:

  • Typically, 2 – 5 years’ experience in a GMP environment with direct packaging related experience advantageous.
  • Bachelor’s degree in relevant science or engineering related discipline.
  • Be a results-oriented person with excellent organizational, communicational and team development
    skills with an ability to successfully interact with people, create a team environment and generate
  • Experience in supporting major investigating manufacturing investigations, CAPA’s and
    Change Controls and ownership of Minor Deviations.
  • Demonstrated understanding and use of RFT techniques and lean manufacturing concepts
  • Strong ability to lead, challenge and positively influence in an interactive team environment
  • Strong computer skills - knowledge of MES, PAS-X, SAP, Spotfire, PI Vision and Maximo

For more information contactRuth Hollandon087 7822 [email protected]