Cagents·25 days ago
25 days ago
Computer Systems Validation Engineer
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What you'll do
- 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 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
- 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
What they're looking for
- 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
- 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
Nice to have
- Experience in biotech or pharmaceutical environments preferred over medical device
- Experience with multiple automation and manufacturing execution systems is highly desirable
- Data integrity assessment/remediation experience is a plus
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
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
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Company
Cagents
Boston, United States of America
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