CSV Engineer

SimoTech • Indianapolis, IN

2d • Hybrid

About The Position

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.

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.

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees