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.
• 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 & 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.
• 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.
• 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.
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