13687 – CSV Engineer – Tipperary Contractor

Purpose:

Reporting to the Automation/IT Project Manager and CSV Lead, specifically responsible for Computer System Validation. The CSV senior engineer will be responsible for the development of key AIT quality documents, such as Quality Assurance (QAPs) test plans, Quality assurance summary reports, ensuring adherence to company and regulatory standards. Required to work closely with Automation and IT teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems. Review and ensure vendors compliance with company quality standards. Represent the CSV function at Automation, IT and other project meetings, as required.

Responsibilities:

• Successful candidate will be capable of acting as the CSV SME for the project team and providing a standardised CSV approach across capital projects, as defined by the CSV lead.
• 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 Specification, Requirements Traceability Matrix , Functional Specification ,Design Specification ,Code Review Test specification/test script Etc.
• Work closely with the QA-IT function and ensure their requirements are met in all deliverables.
• Align with the company’s HPV program: leverage existing documents & expertise where feasible.
• Approval 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.

Minimum Qualifications and Experience: 

• Fluent in English, written and verbal.
• Minimum of 5 years’ experience in a similar role in life sciences, ideally in
Pharmaceutical manufacturing.
• Expert knowledge of GAMP5.
• Strong experience in one or all the following systems: DCS (DeltaV), PLC/SCADA
systems, MES, OSI PI, Automated Utility Systems, Lab Systems, Building Automation Systems.
• 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).
• Relevant Computer Science or Engineering degree or equivalent.
• Previous experience of API Manufacturing and/or Oral Solid Dose will be
advantageous.
• Previous experience of high containment manufacturing (OEB4/OEB5) will be advantageous.
• Previous experience working with paperless validation systems (Kneat) will be advantageous.

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