Website Ref: TPM04239
A MES Engineer is required for a biopharmaceutical company in Carlow. The MES Engineer will be responsible for supporting the delivery of an expansion to existing MES system (Werum PasX). The MES engineer will participate in the development of key AIT quality documents, such as Quality Assurance (QAPs) test plans, Quality assurance summary reports, ensuing adherence to all Automation documentation.
- 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.
- This candidate will review and ensure vendors compliance with company quality standards.
- He/she will represent the MES function at AIT and other site project meetings, as required.
- 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 QAIT (Quality) function and ensure their requirements are met in all deliverables.
- Generate and Execute 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.
- 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.
- Fluent in English, written and verbal.
- Minimum of 3 years’ experience in a similar role, ideally in the Pharmaceutical industry.
- Expert knowledge of GAMP5.
- Strong experience in one or all of the following systems: MES Werum PasX OSI PI.
- Usual place of work will be in Carlow Ireland, the successful candidate may sometimes be required to attend meetings at other company or Vendor sites.
- 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).
To apply for this job email your details to firstname.lastname@example.org.