CSV Engineer 1701
Posted 2 days 1 hour ago by Simotechnology
Whatis it like to work at SimoTech? With a strong collaborative teamworkculture based on respect, trust, and excellence, we play a criticalpartnering role to our clients' life-changing supply of products topatients. In return, there is excellent salary, benefits, careerprogression, educational support andmuch more.
SimoTech has a new opportunity for a CSV Engineer to join our team, support ing the validation for a Drug Product Facility p roject for our biopharmaceutical client based in Co. Dublin.
The successful candidate will have a minimum of 6 years ' experience in developing and validati ng automation documentation and working closely with SMEs, vendors, & quality teams to ensure compliance with regulations, timelines and operational needs.
- Responsible for authoring and managing the C&Qplan, PCS automation validation plans, URS, FAT, IOQ documentation and summaryreports, in collaboration with cross-functional teams.
- Monitor FAT and IOQ execution activities, ensuringalignment with test script intent, identifying & resolving protocol issuesand executing CSV related tests on lines and equipment.
- Ensure all automation deliverables comply withregulations and industry best practice standards.
- Maintain consistency and traceability across C&Qplans, automation plans, URS, FAT, SAT, IOQ, STQM/RTM and summary reports.
- Develop and maintain templates for all SDLCdeliverables in compliance with client standards, ensuring consistentimplementation of validation strategies. Deliverables include, but are notlimited to, Requirements Specifications, Requirements Traceability Matrices(RTM), Functional Specifications, Data Integrity Assessments, DesignSpecifications, Code Reviews, and Test Specifications/Test Scripts.
- Conduct system walkdowns and verification oftechnical documentation and drawings, including P&IDs, as-built drawings,and related engineering documentation, to ensure accuracy and compliance.
- Identify risks and recommend improvements to theC&Q and automation qualification strategy, documentation quality, and testexecution.
- Share key learnings to facilitate effectiveknowledge transfer for future projects.
- Bachelor'sdegree in Engineering, Computer Science, Life Sciences or similar.
- Minimum6 years' experience in GMP and validation disciplines, with a strongunderstanding of pharmaceutical design, build, commissioning, & validationprocesses, and their alignment with EU and US FDA regulatory requirements.
- Knowledgeof regulatory compliance such as 21 CFR Part 11, Eudralex Annex 11, and GAMP 5.
- Solidtechnical understanding of computer systems and PLC automation systems,enabling FAT and IOQ protocols to be authored with support from other SMEs.
- Experienceworking with one or more of the following systems: MES, PI Data Historian, PCS,Lab systems, QBMS, or inspection line control systems.
- Experienceworking with paperless validation systems (Kneat) would be an advantage.
- Demonstrateexcellent interpersonal and communication skills, with strong attention todetail and the ability to work effectively across cross-functional teams.
- Role provides ahigh degree of autonomy to allow the successfulcandidate to reach their fullpotential.
- Develop newskills and enhance technical ability by working withinnovative technologies in a multi- disciplinedenvironment.
- Opportunity towork with large corporate clients