Website Ref: TPM04028
Senior Delta V Automation Engineer is required for a biotech in Carlow. The successful candidate will be responsible for the development of key documentation, test protocols, and for ensuing adherence GAMP practices. This candidate will be required to work closely with the AIT teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.
- The Senior DeltaV engineer will be responsibility to the delivery, and qualification of DeltaV Process Areas.
- Be part of the DeltaV team contributing to the completion of a large-scale project.
- Support the project on a day to day basis for the DeltaV System including: Design and test documentation generation, reviewing and approving.
- Supporting of PLC system interfacing with the DCS system.
- Design, Review, Approve SDLC deliverables, compliant with 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 QAIT and ensure their requirements are met in all deliverables.
- Participate in Hardware and Software FATs.
- Provide input to the development of realistic project schedules and document trackers.
- Work closely with suppliers / integrators to ensure compliance with 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.
- 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.
- Shift work maybe introduced and if so, you will be expected to work shift hours. Shift pattern will be open to change depending on business requirement.
Qualifications & Experience:
- Relevant Computer Science or Engineering degree or equivalent.
- Minimum of 5 years’ experience in a similar role, ideally in the Pharmaceutical industry.
- Working knowledge of GAMP5.
- Excellent knowledge of DeltaV.
- Fluent in English, written and verbal.
- Knowledge of the following systems beneficial: PLC/SCADA and OSI PI.
- The successful candidate may sometimes be required to attend meetings at other sites, off-site or at the PM office in Cork.
- Excellent computer skills, proficient in the use of the following Microsoft tools: Excel, SharePoint, Word and PowerPoint.
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