CSV Engineer 1701

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 1701

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.
  

Requirements

Qualifications &
Experience

• Bachelor’s
  degree in Engineering, Computer Science, Life Sciences or similar.
  
• Minimum
  6 years’ experience in GMP and validation disciplines, with a strong
  understanding of pharmaceutical design, build, commissioning, & validation
  processes, and their alignment with EU and US FDA regulatory requirements.
  
• 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
  working with one or more of the following systems: MES, PI Data Historian, PCS,
  Lab systems, QBMS, or inspection line control systems.
  
• Experience
  working with paperless validation systems (Kneat) would be an advantage.
  
• Demonstrate
  excellent interpersonal and communication skills, with strong attention to
  detail and the ability to work effectively across cross -functional teams.
  

Benefits

What SimoTech Can
Offer

• Role provides a
  high degree of autonomy to allow the successful
  candidate to reach their full
  potential.
  
• Develop new
  skills and enhance technical ability by working with
  innovative technologies in a multi - disciplined
  environment.
  
• Opportunity to
  work with large corporate clients