The purpose of this role is to ensure Automation systems are operated, improved and maintained to meet Customer and compliance requirements.
Responsibilities of this role include:
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.
- 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.
- 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. Attendance at FAT’s etc.
- 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 the EirGen Plant Network
- Provide automation requirements and implement solutions for new products and/or capacity expansions
The ideal candidate for this role will have:
- 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.