Reporting to the site’s 2 AIT CSV Lead, specifically responsible for Computer System Validation (CSV.) The CSV engineer will be responsible for the development of key AIT quality documents, such as Quality Assurance (QAPs) and test plans, and for ensuing adherence to the QAPs. This candidate will be required to work closely with the site’s AIT teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.
• Develop and maintain Qualification Plans and Test Plans, aligned with the overall project C&Q plan and with the leveraging strategy.
• Develop templates for all SDLC deliverables, compliant with company standards, to ensure consistent implementation of the validation strategy, including but not limited to:
Requirements Traceability Matrix
Test specification/test script
• Work closely with the QAIT function and ensure their requirements are met in all deliverables.
• Align with the company’s HPV program: leverage existing documents & expertise where feasible.
• Approver of all AIT SDLC deliverables, ensuring compliance with standards.
• Provide FAT oversight and perform leveraging assessments.
• Provide guidance and support to AIT team members tasked with delivery of SDLC documents.
• Provide input to the development of realistic project schedules and document trackers.
• Work closely with suppliers / integrators to ensure compliance with company standards.
• Participate in, and support, relevant project meetings.
• Liaise with the various stakeholders on the overall project to ensure clear communication between all parties in relation to AIT validation requirements.
• Support the Automation team with field instrument configuration, connectivity to their associated control system and loop testing.
• Relevant Computer Science or Engineering degree or equivalent.
• Minimum of 8 years’ experience in a similar role, ideally in the Pharmaceutical industry.
• Expert knowledge of GAMP5.
• Fluent in English, written and verbal.
• Strong experience in one or all of the following systems: DeltaV, PCS7 (or other PLC/SCADA), OSI PI.
• Usual place of work will be in Carlow, Ireland. The successful candidate may sometimes be required to attend meetings at other sites or off-site.
• Excellent computer skills, proficient in the use of the following Microsoft tools: Excel, SharePoint, Word and PowerPoint.
• Strong interpersonal and communication skills (verbal and written).
Purpose: Reporting to the Automation/IT Project Manager and CSV Lead, specifically responsible for Computer System Validation. The CSV senior engineer...Apply For This Job
Purpose: The individual in this position implements policies and procedures to validate/qualify computer systems. Plans, coordinates, and participates in a...Apply For This Job