- A vacancy has arisen for an Automation Engineer at our client’s biopharmaceutical facility in Co. Waterford.
- The purpose of the role is 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 Duties and Responsibilities:
- 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.
- 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.
Qualifications and 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 system
- 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.
- Disciplined and compliant approach.
- 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 and Annex 11.
- Strong understanding of IP based networks, DeviceNet, Profinet, etc.
- Strong understanding of RS485 networks especially Profibus an advantage. Behaviours
- Focus on people and process.
- Motivating others positively
- Ability to work independently and in teams. Have strong interpersonal skills, a professional approach with excellent written and verbal communication skills.
- Be driven by task / project and will show flexibility to ensure results are achieved.
- Self-starter and accustomed to setting personal goals. Good judgment and strong initiative.
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100
Please note, we do not require agency assistance with this role.