CSV Engineer 1739

SimoTechnology; Dublin; Remote; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Autonomy

Skills development

Capital projects exposure

Job summary

SimoTech in Ireland is seeking a CSV Engineer to join our team for the validation of a Drug Product Facility project in Co. Dublin.

The role requires a minimum of 6 years of experience in developing and validating automation documentation and collaborating with SMEs, vendors, and quality teams to meet regulatory timelines and operational needs. The successful candidate will author and manage C&Q plans, URS, FAT, IOQ, and related reports, ensuring compliance with EU and US regulatory

Qualifications

• Minimum 6 years in GMP and validation disciplines.
• Experience with C&Q plans, URS, FAT, IOQ and validation docs.
• Knowledge of 21 CFR Part 11, Eudralex Annex 11, GAMP 5.
• Strong technical understanding of computer systems and PLC automation.
• Experience with MES, PI Data Historian, PCS, Lab systems, QBMS.
• Kneat experience would be advantageous.
• Excellent interpersonal and communication skills.

Responsibilities

• Author and manage the C&Q plan, PCS automation validation plans, URS, FAT, IOQ documentation and summary reports with cross-functional teams.
• Monitor FAT and IOQ execution activities, align with test script intent and resolve protocol issues.
• Ensure all automation deliverables comply with regulations and best practices.
• Maintain traceability across C&Q plans, automation plans, URS, FAT, SAT, IOQ, RTM and reports.
• Develop and maintain SDLC templates, ensuring validation strategy implementation.
• Conduct system walkdowns and verify technical documentation and drawings for accuracy.
• Identify risks and recommend improvements to C&Q and automation qualification strategy.

Skills

GMP validation

Regulatory compliance

PLC automation

Cross-functional collaboration

Technical documentation

Education

Bachelor’s degree in Engineering/CS/Life Sciences

Tools

MES

PI Data Historian

PCS

Lab systems

QBMS

Inspection line control

Job description

What is it like to work at SimoTech? With astrong collaborative teamwork culture based on respect, trust and excellence,we play a critical partnering role to our clients’ life-changing supply ofproducts to patients. In return, there is excellent salary, benefits, careerprogression, educational support and much more.

SimoTech has a new opportunity for a CSVEngineer to join our team, supporting the validation for a Drug ProductFacility project for our biopharmaceutical client based in Co. Dublin.

The successful candidate will have a minimum of6 years’ experience in developing and validating automation documentation andworking closely with SMEs, vendors, & quality teams to ensure compliancewith regulations, timelines and operational needs. This is a fully onsite role.

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

Key Requirements

• 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 a high degree of autonomy to allow the successfulcandidate to reach their full potential.
  
• Develop new skills and enhance technical ability by working withinnovative technologies in a multi-disciplined environment.
  
• Opportunity to work with large corporate clients on exciting capitalprojects.