Computer Systems Validation Engineer

Boston, Massachusetts/Northeast/Full Time

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.

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

• - Team Before Self
• - Respect for Others

This position could report to Rockville, MD or Frederick, MD

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 various platforms including MES, DCS, SCADA, and batch systems

Engage with major systems and platforms such as Rockwell Pharma Suite, Rockwell Automation platforms, Emerson DeltaV, DeltaV Batch, Emerson Syncade, PI, GE, ABB, Siemens, Honeywell, PAS-X, Factory Talk, Factory Logix, 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

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

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

• - 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

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

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

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

• - Prioritizes effectively and ensures accountability
• - Proactively addresses challenges
• - Communicates clearly and professionally
• - Adapts style for technical and non-technical audiences

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

• - Gains support through sound reasoning
• - Promotes innovation and value

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