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Contact Info
Niamh Hlubek
Life Science

+353 87 114 6347
[email protected]
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Details

Automation Engineer


Reference:A000000 (ADMQ-463042) Location: Waterford
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: € Negotiable
May be suitable for: Automation Engineer

A000000 (ADMQ-463042) Automation Engineer

You must have a valid work visa/ permit for Ireland to apply. (Stamp 4 or EU passport).

Our client is a biopharmaceutical company focused on improving patients’ lives by identifying, developing, acquiring and commercialising differentiated and accessible medicines that address unmet medical needs.

The purpose of the role is to provide Automation and Equipment engineering support to site systems and process equipment.

This role requires good judgment and strong initiative. You need to have the ability to effectively prioritise and manage a diversified workload, often to tight deadlines. You should have strong interpersonal skills, a professional approach with excellent written and verbal communication skills.


Duties:

  • 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.
  • Ensure all work carried out, is in compliance with the required standards, conforming to company, cGMP, cGLP, SOP’s and regulatory guidelines.
  • Comply at all times with the Health, Safety and Environmental policy and associated procedures.



Requirements



  • 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 and excellent technical knowledge in all phases of GAMP.
  • Experience with Industrial Ethernet and Scada system.
  • Reading and interpreting PLC code.
  • 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.