Description:
Position Summary
- Reporting to the site Manufacturing Automation Manager, specifically responsible for Automation Systems delivery.
- This candidate will be required to work closely with the Automation Team within the site responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems and end to end eco-system integration of a WWTP (WasteWater Treatment Plant) project.
Key Responsibilities
- As the Automation Engineer for the project, you will work with other Automation resources, Automation vendors and partners to deliver automation systems on time and within budget.
- Develop and/or review SDLC deliverables, from detailed design through to commissioning and qualification (C&Q), handover to Manufacturing Operations, compliant with standards, including but not limited to:
-Requirements Specifications
-Requirements Traceability Matrix
-Functional Specification
-Design Specification
-Code Review
-Test specification/test script
-Factory Acceptance Testing
-System Acceptance Testing
- Work closely with vendors of Automation equipment to ensure deliverables meet project requirements, including the interfacing of new Automation equipment with existing site systems, incl. BMS.
- Work closely with the Digital Data Quality (DDQ), and CSV functions and ensure their requirements are met in all deliverables.
- Participate in Hardware and Software FATs and SATs to ensure requirements and standards are met.
- Follow project schedules and document trackers to assist in the management and control of project deliverables.
- Participate in Automation meetings and support relevant program meetings.
- Liaise with stakeholders on the overall project to ensure clear communication between all parties.
- Ensure Automation compliance with Global Policies, Procedures and Guidelines, regulatory requirements, GxP, and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
Qualifications & Experience.
- Knowledge of and experience with the following systems; Siemens PLC V7 Control Systems, BMS MES.
- Previous experience with WWTP (WasteWater Treatment Plant) automation.
- Relevant experience in Pharmaceutical Electronic Document Management Systems (e.g., GxKneat).
- Hybrid 3 days onsite during requirements and design, moving to 5 days during commissioning.
- Experience in a similar role in the Pharmaceutical industry an advantage
- Advantageous:
-Full understanding and application of SDLC
-Previous experience of Biologics manufacturing
- Fluent in English, written and verbal.
- Excellent computer skills, proficient in the use of the following Microsoft tools: Excel, SharePoint, Word and PowerPoint.
- Computer System Validation understanding, knowledge.
- Strong interpersonal and communication skills (verbal and written).
- Relevant Computer Science or Engineering degree or equivalent