CONTROL AND INFORMATION MANAGEMENT
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Process Owner – Packaging

Job Description
Our client has an aseptic drug product facility, specialising in secondary manufacturing activities Formulation, Vial/Syringe Filling, Lyophilisation and Packaging.
There is a strong culture of continuous improvement and innovation within this company to strive for solutions that improve health outcomes and dramatically improve people’s lives. This company is developing the capability to produce all its medicines in Dun Laoghaire, South Dublin, helping to ensure continuity of supply of medicines as they expand internationally.
CIM are looking for an experienced Process/Manufacturing Engineer to expand an onsite production support service we provide our client.

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.
Normally Mon-Fri 9-5 with some flexibility and a requirement to work extended hours from time to time depending on demands of the job.

Roles and Responsibilities:

  • Ensuring Safety, Quality and Compliance.
  • 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.
  • Provides document generation and SME support input into design, commissioning and validation of equipment, automation and processes as part of multi-function project teams.
  • Setting up work practices and procedures that minimize human error, and work with operations continuous improvement teams to remove sources of error.
  • Own quality records (change control, CAPA, deviations) and deliver to timelines.
  • Support and implement Continuous Improvements projects associated with cost, time and functionality, ensuring that all KPI targets are achieved.
  • Integrate digitalization and analytics into our processes to improve efficiency, competency, data fluency, and streamline science-based decision-making.
  • Identify and autonomously implement continuous improvement opportunities.
  • Creation of solid business cases for improvement ideas.
  • Anticipate risk and builds contingencies to help mitigate impact.
  • Provide data to support management evaluation of performance trends.
  • Creation of solid business cases for improvement ideas.
  • Collaborate with Quality, Process Engineering, Regulatory, and Process Development to implement process improvements.
  • Support of front-line managers through on the floor presence.
  • Review and approval of master batch records.
  • Own and author critical standard operating procedures and supporting documentation/training.
  • Lead and/or support root cause investigations related to performance trends and formal deviations.
  • Support of new product and product reintroductions.
  • Develop, implement and assess solutions for complex problems.
  • Accountable for Delivering Results by:

  • Establishing high performance standards, using measurable goals to track progress and continually raising the bar on performance & expectations.
  • Leading lean initiatives such as Kaizen events, A3 projects, 5S initiatives and CI ideas to create a culture of continuous improvement.
  • Skills and Education

  • 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 co-operation.
  • Experience in supporting major 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.
  • 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.
  • If you are interested or would like to know more about this opportunity, please contact jobs@cim.ie quoting Ref: CIM004 for this position