CSV Engineer

Automation CSV Engineer

We are actively
expanding our US projects team to support a growing portfolio of pharmaceutical
and biotechnology projects across the United States. SimoTech is seeking an
Automation CSV Engineer to join our team. The successful
candidate will support the validation of computerised systems within the
process automation framework, ensuring their compliance with pharmaceutical
industry standards and regulations. The ideal candidate will have extensive
experience as a CSV Engineer in a pharmaceutical environment.

• Develop
  and execute validation strategies for new and existing process automation and
  computerised systems.
  
• Support
  the implementation and validation of DeltaV, Siemens PLC, PI and other
  automation platforms.
  
• Prepare
  and review validation documents including URS, FRS, IQ, OQ, PQ, Validation
  Plans, Summary Reports and Automation Change Pack (ACP’s).
  
• Develop
  and execute PV and PQ protocols to support readiness for commercial
  manufacturing.
  
• Perform
  risk assessments, impact assessments, and manage change controls for validated
  systems.
  
• Create
  and maintain traceability matrices ensuring full alignment between
  requirements, design, and testing.
  
• Identify,
  troubleshoot, and resolve validation deviations and test failures in a timely
  manner.
  
• Execute
  commissioning and qualification test cases to verify system functionality and
  data integrity.
  
• Support
  internal audits, inspection readiness, and preparation activities for
  regulatory licensure (HPRA, EMA, FDA).
  
• Ensure
  all validation work complies with 21 CFR Part 11, GAMP 5, EU Annex 11, and site
  quality standards.
  
• Collaborate
  with IT QA to ensure compliance and drive continuous improvement in validation
  processes.
  
•  Provide
  validation and regulatory training to team members to support the transition
  from project phase to operations.
  
  

Requirements

• Bachelor’s
  Degree in Engineering, Information Systems, Computer Science or Life Sciences.
  
• Minimum
  of 5 years’ experience as a CSV Engineer in a pharmaceutical environment.
  
• Experience
  supporting process automation systems and manufacturing technologies from a CSV
  perspective.
  
• Good knowledge of 21 CFR Part
  11, EU Annex 11, GAMP5 and data integrity guidelines.
  
• Hands
  on experience validating DeltaV and Siemens PLC automated systems.
  
• Excellent
  Communication and stakeholder management skills
  
• Ability to
  work independently while contributing effectively within a team environment
  
• Eligibility
  to work in the United States.
  

Benefits

• What
  SimoTech Can Offer
  Opportunity
  to work with large corporate clients on exciting capital projects.
  
• 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
  
• We offer
  a hybrid working model for this role, balancing flexibility with business
  needs.