- Experience Level
- Experienced (non-manager)
On behalf of my client, I am recruiting for an Automation Engineer.
The successful candidate will be responsible for providing 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
• 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
• 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.
• 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.
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