Automation Engineer- Sterile Fill Finish
ICDS RECRUITMENT
WATERFORD
Automation Engineer- Waterford. Core Purpose: To provide Automation and Equipment engineering support to site systems and process equipment and to ensure they are operated, improved and maintained to meet Customer and compliance requirements. Core Responsibilities: Automation systems. Facilitate internal resources and outside vendors in developing technical solutions for automated equipment. Interface with equipment vendors to ensure successful equipment delivery, integration and validation. Maintain PLC automation systems in a validated state in compliance with site change control. Understand the requirements of computer systems validation and ensure compliance is maintained. Act as operations support for Fill Finish and Oral Dose facilities. Interface with Operations, IT, QS and QA groups to successfully validate software systems and adherence to life cycle management and system maintenance. Provide automation requirements and implement solutions for new products and/or capacity expansions. Support disaster recovery and back up procedures and processes to ensure business impact is minimized in the event of a failure. Provide technical and automation core competency support, including possible off-hours, remote and onsite coverage. This also includes operations / engineering training on basic troubleshooting. Management of Automation vendors during equipment troubleshooting and upgrade activities. Health, Safety and the Environment. Comply at all times with the Health, Safety and Environmental policy and associated procedures. Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do. Quality Compliance. Ensure all work carried out, is in compliance with the required standards, conforming to company, cGMP, cGLP, SOP’s and regulatory guidelines. Take ownership for quality compliance in all activities you are responsible for. Minimum Qualifications & Experience. Engineering degree in Electronics, Electro-mechanical or equivalent training/experience. Minimum of 5 year’s engineering experience within Pharma Industry. Experience with Siemens S7 PLCs and WinCC flexible desirable. Experience with Fill Finish equipment required. Experience working in a cGMP/FDA/HPRA regulated environment. Experience with Industrial Ethernet and Scada systems. Excellent technical knowledge in all phases of GAMP. Reading and interpreting PLC code. Strong understanding of SCADA systems. Reading and interpreting electrical drawings. Knowledge of mechanical systems and manufacturing processes. Understanding of Computer Systems Validation. Strong understanding of how to implement and maintain FDA 21 CFR Part 11 compliant systems and Annex 11. Strong understanding of IP based networks, DeviceNet, Profinet, etc. Strong understanding of RS485 networks especially Profibus an advantage.
1367 days ago