We are actively looking for an Automation Systems Validation (ASV) Engineer to join a growing team on site. The Automation Validation Engineer will be responsible for the Development of Validation Plans for our client’s biotech facility in Dublin West.
• Provide technical support in validation to meet objectives of quality
• Development of Validation Plans, Installation Qualifications (IQs), Operational Qualifications (OQs), Process Qualifications (PQs), and System Summaries
• Pre-approval of Automation Change Packs to ensure the correct testing is included and the correct document updates are being made.
• Post change review of Automation Change Packs to ensure testing was performed as agreed and any test faults correctly documented and closed.
• Perform periodic reviews on Automated Control systems to ensure the validated state of the system is maintained. ASV are also responsible for generating the annual periodic review plan for Automation.
• Perform biennial reviews of Automation Procedures and document updates as needed following the reviews. (Periodic reviews and biennial reviews must be performed to meet agreed timings.)
• Review/approval of test documents for new/modified code.
• Ensure compliance with site procedures and Regulatory Requirements
• Responsible for assessing the validation of Automation Systems as part of Annual Product Quality Reviews
• A Bachelor’s degree in Computer Science, Computer Engineering, Computer Information Systems, or a related field (Technology Management; Chemical Engineering)
• Minimum of 3 years relevant experience of working within the Pharmaceutical sector
• Must have at least 2 years’ experience implementing and supporting automation systems for manufacturing organizations in the biotechnology or pharmaceutical industries.
• Must have demonstrated experience in the delivery and management of Automation systems in addition to a working knowledge of GAMP software development lifecycle, ANSI/ISA-S88 industry standards
Zenith Technologies, now a Cognizant Company is a world leader in delivering digital transformation solutions to Life Sciences. Through our knowledge and expertise in Automation, MES & Digital, we deliver stable manufacturing systems that are optimised to improve operational efficiencies, whilst maintaining compliance. Our specialist engineering teams have the aptitude to deliver and support Pharma 4.0 architectures and solutions covering all IT, OT and IoT applications, infrastructures and services. Operating across 5 continents and with over 850 skilled employees, Zenith partners with the leading Life Sciences companies globally to provide performance improvements, reduced costs and improve time to market