CSV Engineer 1675

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 1675

Key Responsibilities

• Assist in creating and
  executing validation strategies for new and existing
  automation computerised systems. 
  
• Support the development and
  execution of CSV strategies for new and existing automated and computerised
  systems in a GMP environment.
  
• Support the implementation
  and validation of DeltaV DCS and associated automation systems used in life
  sciences manufacturing.
  
• Prepare and review
  validation documentation, including URS, FRS, Validation Plans, IQ, OQ, PQ,
  traceability matrices, and Validation Summary Reports.
  
• Perform risk -based
  validation activities in line with GAMP 5 principles and regulatory
  expectations.
  
• Execute validation testing,
  identify and manage deviations, and support investigations and corrective
  actions.
  
• Support change control
  activities and assess validation impact for system changes.
  
• Provide validation support
  during internal and external audits and inspections.
  
• Ensure compliance with 21
  CFR Part 11, EU Annex 11, and site quality procedures.
  
• Work collaboratively with
  Quality Assurance, Automation, Engineering, and IT to maintain validation
  compliance and continuously improve CSV processes.
  
  

Requirements

Qualifications &
Experience

• Bachelor’s Degree in
  Engineering, Information Systems, Computer Science or Life Sciences. 
  
• Minimum of 3 years’
  experience as a CSV Engineer, supporting DeltaV automation in a
  pharmaceutical environment. 
  
• Familiarity
  with 21 CFR Part 11, EU Annex 11, GAMP5 and data integrity
  guidelines. 
  
• Working knowledge of
  risk management practices and tools such as FMEA. 
  
• Strong written and
  verbal communication skills with the ability to work in a cross -functional
  team. 
  
• Strong attention to
  detail, organisational and problem -solving skills. 
  

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