Automation Engineer- Pharmaceutical
ICDS Recruitment
Waterford
Automation Engineer. Job Purpose: The ideal candidate will be required to ensure Automation systems are operated, improved and maintained to meet Customer and compliance requirements. The role reports to the Sterile Technical Operations Manager. 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. Provide technical and automation core competency support, including possible off-hours, remote and onsite coverage. Provide technical and automation training to Operations and Engineering personnel on an as-needed basis. Ensure automation systems are maintained appropriately. Adhere to a Life cycle management process for automation systems. Support process investigations and troubleshooting as required. Interface with Operations, IT, QS and QA groups to successfully validate software systems. Support delivery of projects as required, through the review and sign off of specifications, designs and commissioning protocols. Support disaster recovery and back up procedures and processes to ensure business impact is minimized in the event of a failure. Support the integration of Fill Finish and Oral Solid Dose equipment into Plant Network. Provide automation requirements and implement solutions for new products and/or capacity expansions. 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 Electrical, Electronics, Electro-mechanical or equivalent training/experience. Minimum of 3 year’s engineering experience within Industry, preferably Pharma. Experience with Siemens S7 PLCs and WinCC flexible desirable. Experience clean room environment a plus. Experience working in a cGMP/FDA/HPRA regulated environment. Excellent technical knowledge in all phases of GAMP. Skills: Reading and interpreting PLC code. Strong understanding of SCADA systems. Reading and interpreting electrical drawings. Understanding of Computer Systems Validation. Methodical/Analytical approach to problem solving. Be able to work with Operations staff, Maintenance technicians and engineers in a cross-functional team setting. Strong understanding of how to implement and maintain FDA 21 CFR Part 11 compliant systems. Strong understanding of IP based networks, DeviceNet, Profinet, etc. Strong understanding of RS485 networks especially Profibus an advantage. This job originally appeared on RecruitIreland.com.
1776 days ago