Website Ref: TPM03896
A Senior Automation OEM Engineer is required for our client, a global biologics company, based in Carlow. The successful candidate will drive the development and provision of all associated OEM Systems and Equipment. The role involves managing the design and development of OEM hardware and software components and other hardware devices required in manufacturing building or support areas.
- Working with peers in the manufacturing business to understand and capture their user requirements and assist in the provision of same.
- Liaise with the global teams to ensure standards are understood and communicated to system integrators and vendors.
- Project planning and adherence to schedule.
- Utilisation of Project management tools including Risk, Issue, Action and Decision management.
- Ensure the appropriate quality documents as needed for the Life-Science industry, such as Quality Assurance (QAPs) test plans, Quality assurance summary reports (QASR) are in place, and are aligned with the qualification strategy of the project.
- The candidate will be required to work closely with team members both global and local, having responsibility for the full OEM scope and liaise with vendors and partners on the delivery of systems.
- The candidate will review and ensure vendors compliance with quality standards.
- Develop and/or review SDLC deliverables, compliant with standards, including but not limited to: Requirements Specifications, Requirements Traceability Matrix, Functional Specification, Design Specification, Code Review and 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, including MES and Pi Historian.
- 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.
Qualifications & Experience:
- Bachelors Degree in Computer Science or relevant discipline.
- 5 years’ minimum experience in a similar role, ideally in the pharmaceutical industry.
- Strong experience in one or all of the following systems: Siemens PLCs, HMIs and OPC Communication protocols and Historian Software.
- Strong knowledge of project lifecycle and associated deliverables for automation systems
- Excellent computer skills, proficient in the use of the following Microsoft tools: Word, Excel, PowerPoint, Viso, MS Project and Agile PM tools.
To apply for this job email your details to firstname.lastname@example.org.