CSV Engineer 1739

Why SimoTech

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

CSV Engineer 1739

SimoTech has a new opportunity for a CSV
Engineer to join our team, supporting the validation for a Drug Product
Facility project for our biopharmaceutical client based in Co. Dublin.

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

Key
Responsibilities

• Responsible for 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, STQM/RTM and summary reports.
  
• Develop and maintain templates for all SDLC
  deliverables in compliance with client standards, ensuring consistent
  implementation of validation strategies. Deliverables include, but are not
  limited to, Requirements Specifications, Requirements Traceability Matrices
  (RTM), Functional Specifications, Data Integrity Assessments, Design
  Specifications, Code Reviews, and Test Specifications/Test Scripts.
  
• 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.