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Automated Systems Validation Engineer

  1. Dublin
County Dublin
  1. Contract
Competitive
  1. CAPEX Projects
17-04-2024
33698
Automated Systems Validation Engineer - Dublin - 6-Month Contract 

Do you want to work with an exciting company who are an established market leader within their niche field? We have a fantastic opportunity for an Automated Systems Validation Engineer to work at one of their sites based in Ireland.


The Automation Systems Validation Engineer is responsible for the support of the automated systems on site and ensuring the validated state is maintained. This includes the management of personnel, (external or internal) as part of the execution of equipment or facility modification or expansion projects.


Essential Duties and Responsibilities for this role include, but are not limited to, the following:
  • Must be solutions orientated, delivery focused and passionate about supporting production.
  • Must maintain up to date understanding of Data Integrity requirements and ensure Automation processes and strategies are in alignment.  
  • Develop the Standard Operating Procedures (SOP) for the Maintenance and Operation of the Automated Systems.
  • Maintain the validated state of the automated systems.
  • Execute and oversee the Automated Systems Validation activities.
  • Support department to be audit/inspection ready and participate in audits and regulatory inspections as required.
  • Generate documentation and SOPs associated with each of the automated systems.
  • Develop testing documentation
  • Provide technical support to partners within Engineering and Operations for automated systems during the life cycle of the equipment.
  • Manage the specification, contract negotiation, purchasing, development and installation of projects within budget and corporate guidelines.
  • Participate in the development of the Automated System Life cycle documents.
  • Support periodic reviews of Automation and Engineering procedures. 

Requirements:
  • Appropriate Engineering Qualification (preferably B.Sc./ B.E. degree in engineering, with particular emphasis in electrical/electronic, mechanical, or chemical discipline)
  • 3 years of working experience in industry, preferably in a pharmaceutical or relevant GMP manufacturing environment
  • Strong knowledge of FDA and European compliance regulations and GAMP guidelines applicable to computer system validation.
  • Strong knowledge of Data Integrity/ALCOA requirements.
  • Experience in regulatory audits.
  • Knowledge of validation deliverables associated with each step of the computer system life cycle
  • Experience of managing automation projects an advantage
  • Excellent communication and interpersonal skills
  • An ability to work independently

If this sounds like the position for you then please apply today!

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