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Collins McNicholas

The purpose of this role is to represents the Operations function and provide operational and system support to the ongoing NPI requirements of the Drug Substance Operating Unit. The breadth of this role includes working initially through detailed design & procurement and subsequently construction, commissioning, verification/qualification, and production start-up.

Responsibilities

  • Participate in Operational Readiness Activities including Commissioning, Validation and

Verification execution and trouble shoot technical issues.

  • Responsible for right first time creation of SOP, paper batch record and other documentation, as well as all records requirements in MES or future electronic systems
  • Training of colleagues in new processes and equipment which may involve short term shift

based assignment during manufacture of NPI specific batches

  • Completion of activities detailed within the Project schedule.
  • Raise execute and manage change controls relating to NPI.
  • SME for bio-processing operations providing expertise and insight to ensure that facility design

enables safe and efficient operation and rapid product changeover to maximize facility

utilization.

  • Development of innovative, new and lean method of moving from one product to another.
  • Specification and introduction of new materials and consumables for the Multi Product

environment.

  • Liaise with Tech Services, Engineering, EHS, Quality, Automation and external parties

regarding aspects of operating a Multi-Product Facility.

  • Support and lead key meetings on behalf of Operations.
  • Participation in Factory Acceptance Testing for key equipment packages (Travel may be

required).

  • Lead/participate in risk assessment activities.
  • Develop standard work model to align with existing operations.
  • Update 5S plans to include new products requirements.

Qualifications

Education/Experience:

  • Diploma / Bachelors or Equivalent.
  • Familiarity of systems such as MCS, Orchestrate, MES, QTS, SAP, LIMS and PDOCs.
  • 4+ years biopharmaceutical manufacturing experience.
  • In-depth working knowledge of Biopharmaceutical processing.
  • Knowledge of cleaning validation/verification execution.
  • Experience of DS product specific equipment and materials (column resins) would be

beneficial.

  • Experience writing technical documents such as SOPs and batch records.
  • Experience with standard work, 5S and structured problem solving would be beneficial.
  • Excellent communications skills essential.

People/Values

  • Demonstrate the GC OWNIT values
  • Adhere to all HR Policies as appropriate
  • Personal Development plans focus on the 70:20:10 guidelines
  • CI tools/- capability is a key building block for learning & development – Trained and M1

certified.

  • Proactive engagement with key stakeholders.
  • Best practices developed and shared with other teams /sites.
  • Best practices actively sought and copied.
  • Proactive & effective communication within and different functional groups in the Operating Unit.

For a confidential discussion and more information on the role, please contact Sarah Boyle on 016620088 or email sarah.boyle@collinsmcnicholas.ie.

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