Computer Systems Validation Engineer

Are You Ready? CAI is a 100% employee-owned 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 With employee ownership, one person’s success is everyone’s success. We work diligently to accomplish team goals and live our core values: - Team Before Self - Respect for Others - Can-Do Attitude This position could report to Rockville, MD or Frederick, MD 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 #LI-MV1 Are You Ready? CAI is a 100% employee-owned 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 With employee ownership, one person’s success is everyone’s success. We work diligently to accomplish team goals and live our core values: - Team Before Self - Respect for Others - Can-Do Attitude This position could report to Rockville, MD or Frederick, MD 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 #LI-MV1 Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment. CAI Benefits: