CSV Engineer 1701

Simotechnology; Dublin; On-site; EUR 70,000 - 110,000; Full time

Job summary

SimoTech is recruiting a CSV Engineer to support validation for a Drug Product Facility project in Co. Dublin. The role requires 6+ years in GMP and validation, with hands-on experience authoring C&Q plans, URS, FAT and IOQ documentation and leading cross-functional teams.

Deep familiarity with 21 CFR Part 11, Eudralex Annex 11, and GAMP 5 is essential. You will ensure compliance and traceability across validation deliverables, maintain SDLC templates, and drive risk assessment and knowledge

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Life Sciences or similar.
• Minimum 6 years’ experience in GMP and validation disciplines, with strong understanding of pharmaceutical design, build, commissioning, & validation processes.
• Knowledge of regulatory compliance such as 21 CFR Part 11, Eudralex Annex 11, and GAMP 5.
• Solid technical understanding of computer systems and PLC automation systems, enabling FAT and IOQ protocols to be authored with support from other SMEs.
• Experience with MES, PI Data Historian, PCS, Lab systems, QBMS, or inspection line control systems.
• Experience with paperless validation systems (Kneat) would be an advantage.
• Demonstrate excellent interpersonal and communication skills, with strong attention to detail.

Responsibilities

• Authoring and managing the C&Q plan, PCS automation validation plans, URS, FAT, IOQ documentation and summary reports, in collaboration with cross-functional teams.
• Monitor FAT and IOQ execution activities, ensuring alignment with test script intent, identifying & resolving protocol issues and executing CSV related tests on lines and equipment.
• Ensure all automation deliverables comply with regulations and industry best practice standards.
• Maintain consistency and traceability across C&Q plans, automation plans, URS, FAT, SAT, IOQ, RTM and summary reports.
• Develop and maintain templates for all SDLC deliverables in compliance with client standards, ensuring consistent implementation of validation strategies.
• Conduct system walkdowns and verification of technical documentation and drawings, including P&IDs, as-built drawings, and related engineering documentation, to ensure accuracy and compliance.
• Identify risks and recommend improvements to the C&Q and automation qualification strategy, documentation quality, and test execution.
• Share key learnings to facilitate effective knowledge transfer for future projects.

Skills

GMP knowledge

Regulatory compliance

Cross-functional collaboration

Communication skills

Attention to detail

Education

Bachelor’s degree in Engineering, Computer Science, Life Sciences or similar

Tools

MES

PI Data Historian

PCS

Lab systems

QBMS

inspection line control systems

Job description

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.

Key Responsibilities

• 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.
  

Requirements

Qualifications &Experience

• 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.
  

What SimoTech CanOffer

• 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