Department: Drug Substance Proteins
Position Reports to: NPI Operations Lead
The purpose of this role is to represents the Drug Substance Operations function by providing
Multiproduct Changeover oversight to the ongoing NPI requirements of the Drug Substance Operating Unit. The breadth of this role includes all current and future New Product Introductions in the DS building (excluding SSF) acting as SME for the Drug Substance Multiproduct Manufacturing Strategy and PCO (Product Changeover) Processes.
The position is part of the New Product Introduction (NPI) operations team. The Multiproduct
Changeover Specialist is responsible for providing PCO support to the operating unit, ensuring that NPI Operations project deliverables and Operations Readiness deliverables are completed as intended to support the manufacture NPI related batches (e.g. water trial, engineering runs, DEMO batches and Process Validation studies). Responsibility includes all support activities and operational functions necessary to ensure successful completion of project objectives.
This project role focuses on tasks including but not limited to; detailed design/process mapping, closure analysis, risk assessment, PCO SOP & PBR document generation, technician training, standard work capability, process understanding in support of orchestrate model development. The role will also include supporting and resolving technical and operational issues during NPI PCO related batch execution.
NPI Operations Manager
NPI Multiproduct Changeover Specialist
- Leader of CI efforts to deliver clear, robust, efficient and effective PCO processes and systems for LEWA, Inoculum Laboratory and Cryovessels using a Zero Defects approach.
- High level of understanding of NPI cleaning validation programme.
- SME on product specific equipment and materials (column resins) for outgoing and incoming products to ensure all necessary equipment is PCO complete and/or prepared for subsequent campaign.
- Plan Co-Ordination and Execution of PCO activities with Operations, Operations Support, Technical Operations, Technical Services, QA Operations and QC.
- Plan Co-Ordination and Execution of Column Packing Activities with Operations, Operations Support, Technical Operations, Technical Services, QA Operations and QC.
- Assessment of new processes and equipment during NPI for impact to PCO processes and identify any unique elements to ensure PCO can be executed RFT.
- Participate in Operational Readiness Activities related to PCO and column packing.
- Responsible for right first time creation of PCO SOP, batch record (electronic and paper) and other documentation.
- Training of colleagues in new processes and equipment.
- Completion of activities detailed within the Project schedule.
- Raise execute and manage change controls relating to PCO as required.
- 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.
- 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.
- Lead/participate in risk assessment activities.
- Develop PCO standard work model to align with existing operations.
- Team leadership and management of NPI System Specialist Contractor(s) working within NPI & PCO scope.
- Plan and manage campaign start up and wind down activities associated with each product
- Diploma / Bachelors or Equivalent.
- Familiarity of systems such as MCS, Orchestrate, MES, QTS, SAP, LIMS and PDOCs.
- 6+ 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.
Working Patterns and Duration
Day based Monday to Friday
In order to be considered for this position you need to be legally eligible to work in Ireland.