Project MES Engineer – Co. Carlow
Role Summary:
- A new vacancy has arisen for the role of a MES Engineer at our client’s busy pharmaceutical site in Co. Carlow.
- Reporting to the MES Lead, 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 site 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 site quality standards.
- He/she will represent the MES function at AIT and other site project meetings, as required.
Core Duties and Responsibilities:
- 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 site 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 site 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.
Minimum Qualifications and Experience:
- Relevant Computer Science or Engineering degree or equivalent.
- 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.
- Fluent in English, written and verbal.
- Usual place of work will be on site in Co. Carlow Ireland. The successful candidate may sometimes be required to attend meetings at other company sites 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:
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100
recruitment@prochem.ie
Please note, we do not require agency assistance with this role.
