Réalta Technologies are currently hiring for an Automation Engineer to provide Automation and Equipment engineering support to site systems and process equipment for a Pharmaceutical client of ours based in Waterford.
Responsibilities:
1. Facilitate internal resources and outside vendors in developing technical solutions for automated equipment.
2. Interface with equipment vendors to ensure successful equipment delivery, integration and validation.
3. Maintain PLC automation systems in a validated state in compliance with site change control.
4. Understand the requirements of computer systems validation and ensure compliance is maintained.
5. Act as operations support for Fill Finish and Biologics Tech Development.
6. Interface with Operations, IT, QS and QA groups to successfully validate software systems and adherence to life cycle management and system maintenance.
7. Provide automation requirements and implement solutions for new products and/or capacity expansions.
8. Support disaster recovery and back up procedures and processes to ensure business impact is minimized in the event of a failure.
9. Provide technical and automation core competency support, including possible off-hours, remote and onsite coverage. This also includes operations / engineering training on basic troubleshooting.
10. Management of Automation vendors during equipment troubleshooting and upgrade activities.
11. Ensure all work carried out, is in compliance with the required standards, conforming to company, cGMP, cGLP, SOP’s and regulatory guidelines.
Requirements:
1. Engineering degree in Electronics, Electro-mechanical or equivalent training/experience.
2. Minimum of 5 year’s engineering experience within Pharma Industry.
3. Experience with Siemens S7 PLCs and WinCC flexible desirable.
4. Experience with Fill Finish equipment required.
5. Experience working in a GAMP regulated environment and experience with 21 CFR Part 11 and EU Annex 11.
6. Strong understanding of SCADA systems and experience with reading and interpreting electrical drawings.
7. Knowledge of work in a Clean Room environment and knowledge of mechanical systems and manufacturing processes.
8. Methodical/Analytical approach to problem solving.
9. Be able to work with Operations staff, Maintenance technicians and engineers in a cross-functional team setting.
10. Strong understanding of IP based networks, Profinet, Profibus, etc.
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