Pharmaceutical & Biotechnology
Automation Engineer
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Contract
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Sligo, County Sligo, Ireland
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42054619
PE Global is recruiting for a Senior Automation Engineer on behalf of our biopharmaceutical client in North Dublin. This is an initial 12-month contract role.
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
Interested candidates should submit an updated CV.
Please click the link below to apply, call Paul Wheatley on 083 094 0199 or alternatively send an up-to-date CV to paul.wheatley@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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