Automation CSV Engineer
1 month ago
Cork city, Ireland | Posted on 01/19/2024
- Industry Pharma/Biotech/Clinical Research
- State/Province Cork
- City Cork city
- Country Ireland
Horizon Controls Group is currently looking to recruit an experienced Automation CSV Engineer, to work on our client site, a leading pharmaceutical site in the Cork area. This role will be predominantly a hybrid home/site approach with full on-site work when required on site.
Job Purpose:
- Works closely with projectstakeholders (System Owners, QA, IT) to effectively and efficiently implementnew systems, system upgrades, or system modifications
- Reporting to the Automation/IT Project Manager and CSV Lead, specifically responsible for Computer System Validation. The CSV senior engineer will be responsible for the development of key AIT quality documents, such as Quality Assurance (QAPs) test plans, Quality assurance summary reports, ensuring adherence to regulatory standards.
- Successful candidate will be capable of acting as the CSV SME for the project team and providing a standardised CSV approach across capital projects, as defined by the CSV lead.
- 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 client 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.
- Work closely with the QA-IT function and ensure their requirements are met in all deliverables
- Approval of all 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 client standards
- Participate in, and support, relevant project meetings
- Manages CSV projects under a GAMPlifecycle framework
- Fluent in English, written and verbal.
- Minimum of 5 years’ experience in a similar role in life sciences, ideally in pharmaceutical manufacturing.
- Expert knowledge of GAMP5.
- Experience in the following systems is desired; ABB DCS (800XA, Advant, MOD300), Emerson DeltaV, similar DCS systems
- Experience in the following systems would be advantageous: PLC/SCADA systems, MES, OSI PI, Automated Utility Systems, Lab Systems, Building Automation Systems.
- 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).
- Relevant Computer Science or Engineering degree or equivalent
- Previous experience working with paperless validation systems (Kneat) will be advantageous
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