Purpose
This is an 11 month contract
Reporting to the Carlow AIT OEM Lead, specifically responsible for OEM Systems. This candidate will be required to work closely with the Carlow AIT teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.
Responsibilities
• Develop and/or review SDLC deliverables, compliant with the company’s standards, including but not limited to:
– Requirements Specifications
– Requirements Traceability Matrix
– Functional Specification
– Design Specification
– Code Review
– Test specification/test script
• Work closely with vendors of OEM equipment to ensure deliverables meet project requirements, including the interfacing of new OEM equipment with existing site systems, incl. MES and Pi Historian.
• Work closely with the computer system validation (CSV) and quality functions and ensure their requirements are met in all deliverables.
• Participate in Hardware and Software FATs and SATs.
• Provide input to the development of project schedules and document trackers.
• Participate in, and support, relevant project meetings.
• Liaise with stakeholders on the overall project to ensure clear communication between all parties.
• Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
Minimum Qualifications and Experience
• Relevant Computer Science/Engineering degree or equivalent
• Minimum of 3-5 years’ experience in a similar role, ideally in the pharmaceutical industry.
• Excellent computer skills, proficient in the use of the following Microsoft tools: Word, Excel, Visio and PowerPoint.
• Strong interpersonal and communication skills (verbal and written).
• Fluent in English, written and verbal.