Computer Systems Validation Engineer

Cagents; Indianapolis (IN); On-site; USD 90,000 - 130,000; Full time

Job summary

CAI is a professional services company established in 1996 with 700+ professionals worldwide, offering commissioning, qualification, validation, startup, project management, and other services for FDA-regulated industries.

We seek a Computer Systems Validation professional to author GxP documentation, create test scripts, and ensure 21 CFR Part 11 compliance across MES, DCS, SCADA, and batch systems, collaborating with client teams to deliver compliant validation solutions.

Qualifications

• Bachelor’s degree in CS or Engineering; equivalent experience may be accepted.
• Minimum of 3+ years of computer systems validation experience.
• Experience in biotech or pharmaceutical environments preferred.
• Familiarity with GAMP and FDA 21 CFR Parts 11, 210, 211.
• Knowledge of S88/S95 batch control standards.
• Experience with Rockwell DeltaV and related systems.
• Willingness to travel domestically and internationally.
• Authorized to work in the U.S. without current or future sponsorship.

Responsibilities

• Author GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports)
• Generate and execute test protocols and scripts
• Ensure adherence to 21 CFR Part 11 and data integrity principles
• Review and contribute to validation plans and risk assessments
• Support CSV activities across MES, DCS, SCADA, and batch systems

Skills

Communication

Documentation

Regulatory Knowledge

Education

Bachelor’s degree in Computer Science or Engineering

Tools

Rockwell DeltaV

DeltaV Batch

Rockwell PharmaSuite

FactoryTalk

Wonderware

iFix

Job description

Are You Ready?

CAI is a professional services company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, startup, project management, and other consulting services associated with operational readiness to FDA-regulated and other mission-critical industries.

Our approach is simple—we put the client’s interests first, we don’t stop until it’s right, and we do whatever it takes to get there.

Our Foundational Principles

• We act with integrity
• We serve each other
• We serve society
• We work for our future

We work diligently to accomplish team goals and live our core values:

Team Before Self

Respect for Others

Can-Do Attitude

Key Responsibilities

Documentation & Compliance

• Author GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports)
• Generate and execute test protocols and scripts
• Ensure adherence to 21 CFR Part 11 and data integrity principles
• Review and contribute to validation plans and risk assessments

System & Industry Expertise

• Support CSV activities across various platforms including MES, DCS, SCADA, and batch systems
• Engage with major systems and platforms such as Rockwell PharmaSuite, Rockwell Automation platforms, Emerson DeltaV, DeltaV Batch, Emerson Syncade, PI, GE, ABB, Siemens, Honeywell, PAS‑X, FactoryTalk, FactoryLogix, PLM, Simatic, iFix, Wonderware
• Apply knowledge of GAMP and compliance expectations (21 CFR Parts 210, 211, 11)
• Utilize familiarity with S88/S95 batch control standards
• Apply working knowledge of recipe authoring, batch recipe development, and S88-based recipe structures across systems such as DeltaV and Rockwell

Client Support & Technical Execution

• Support client engagements with strong customer-service orientation
• Perform system assessments and remediation related to data integrity
• Collaborate with client teams to ensure validation compliance and delivery

Qualifications and Experience

• Bachelor’s degree (BS/BA) in Computer Science, Engineering, or related field; equivalent experience may be accepted
• Minimum of 3+ years of experience in computer systems validation
• Experience in biotech or pharmaceutical environments preferred over medical device
• In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211)
• Familiarity with S88/S95 batch control standards
• Experience with Rockwell platforms, DeltaV systems, and recipe authoring in batch environments strongly preferred
• Experience with multiple automation and manufacturing execution systems is highly desirable
• Data integrity assessment/remediation experience is a plus

Other Requirements

• Excellent oral and written communication skills in English
• Ability to travel domestically and internationally as required
• Willingness to work paid overtime when needed
• Must be authorized to work in the U.S. without current or future sponsorship

Critical Competencies

Influence Strategy

• Pursues opportunities based on organizational fit and strategy
• Identifies high-impact, innovative solutions

Satisfy the Customer

• Anticipates and meets client needs
• Delivers high-quality solutions and maintains satisfaction

Plan for Success

• Aligns business goals with execution plans
• Allocates resources and builds risk mitigation strategies

Pursue Execution

• Prioritizes effectively and ensures accountability
• Proactively addresses challenges

Tailor Communication

• Communicates clearly and professionally
• Adapts style for technical and non-technical audiences

Build Partnerships

• Builds cross-functional networks
• Promotes collaboration and stakeholder engagement

Influence Others

• Gains support through sound reasoning
• Promotes innovation and value

Develop Self and Others

• Demonstrates integrity and commitment to growth
• Builds effective relationships internally and externally

We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society.

This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).