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.
The position is part of the New Product Introduction (NPI) operations team. The NPI Operations System Specialist is responsible for providing process, equipment, system 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 which may include short term shift based assignment during manufacture of NPI specific batches.
This project role focuses on tasks including but not limited to; detailed design/process mapping, closure analysis, risk assessment, SOP & PBR document generation, technician training, standard work capability, 5S, EBR (PMX/AMPS) generation, process understanding in support of orchestrate model development. The role will also include supporting and resolving operational issues during NPI related batch execution.
- 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 executes and manages 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
- 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
- Demonstrate the GC OWNIT values
- 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.