Description:
Eli Lilly and Company is building a state of the art, Next Generation Biotech facility in Limerick Ireland. To facilitate bringing the plant on-line, several operational roles will be necessary to execute all the activities to start-up the facility, create multiple business processes, complete Process Validation, then assume day to day production activities.
The Production Operator will be responsible for working closely with Operations Process Teams, Functional support personnel (Engineering, MS/TS, IDS), Project Leads, and others to carry out tasks to support an effective facility start-up followed by routine operations delivery.
Initially, the Production Operator will be responsible for carrying out tasks associated with bringing the new facility on-line. During this phase of the project the production operator will play a key role in commissioning & qualification of the plant equipment and systems followed by process qualification activities. Once the plant is running, the operator will be responsible for running a nearly fully automated process to manufacture active pharmaceutical material.
Key Objectives/Deliverables
- Start-up Activities
- Equipment set-up and qualification activities. (C&Q, F.A.Ts, Process Qualification)
- Document writing (Drafting W.Is, SOPs etc)
- Testing for operations digital platforms (MES, Syncade, DeltaV, SAP etc)
- Other tasks as defined by leadership required for start-up.
- Work cross functionally with QC, Logistics to develop material flow processes.
- Training of new operators on Upstream & Downstream manufacturing
- Support the creation of operations systems and processes in a start-up environment.
- Routine Operations
- Execute batch record and procedure instructions
- Competent in monoclonal antibody drug substance manufacturing and the main types of processes utilised e.g. cell culture, filtrations, viral inactivation, column chromatography, etc.
- Competence in basic engineering equipment used in bulk manufacturing e.g. pipe-work, valves, pumps, vacuum etc.
- Navigation of the Distributed Control System (DCS) to monitor and manage the production process
- Good Manufacturing Practices (GMP)-regulated environment and application of Good Documentation Practices (GDP) for manufacturing tickets, quality incident notification etc.
- Health, safety & environmental-regulated environment and application of Health & Safety/Process Safety standards in order to execute key/critical GMP duties.
- Use structured Problem Solving to address production issues as they arise Identify abnormal processing conditions and escalate appropriately.
- Provide information to technical services, engineering, and automation to improve batch records, procedures, and automation.
- Maintain process/work areas in a clean and organized state and maintain good housekeeping documentation.
- Working with Maintenance and Technical Support to respond appropriately to potential process upsets or equipment failure.
- Be first point of investigation and escalate when appropriate if there is a problem or an event (spill/deviation/incident) during processing.
- Carry out / Receive a detailed production Shift Handover and ensure any issues/problems that have occurred are communicated effectively and actioned appropriately.
- Training and qualification on all specified unit operations within the building.
Basic Requirements
- Previous experience in Biotech Operations - 2+ years
- Strong interpersonal and communication skills
- Must exhibit a high level of attention to detail.
- Demonstrate technical and problem solving skills.
- Be able to follow written and verbal directions.
- Experience with computer systems related to business applications (e.g DeltaV, MES, Automated recipe driven processing)
- Work individually and with groups and provide thorough communication.