Loading...
Home / Computer Systems Validation Engineer

Computer Systems Validation Engineer

Cagents at a glance

SEC filings mentioning "Cagents": 1 — search EDGAR

Cagents

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
#LI-MV1

To apply for this job please visit jobs.lever.co.

Explore Cagents online

What people say about Cagents

Recent news

Aggregated from public discussions and news; opinions are the authors’ own.

Working in Indianapolis, Marion County

Weather right now in Indianapolis, Marion County: checking… · Local time: · Air quality: · Daylight: · UV index:

Indiana is a state in the Midwestern region of the United States. It borders Lake Michigan to the northwest, Michigan to the north and northeast, Ohio to the east, the Ohio River and Kentucky to the south and southeast, and the Wabash River and Illinois to the west. Nicknamed "the Hoosier State", Indiana is the 38th-largest by area and the 17th-most populous of the 50 states. The state's capital a

🇺🇸 Relocation safety for US: Exercise Normal Caution — via Warnely, CC BY 4.0

National unemployment rate in US: 4.2% — via World Bank

  • Elevation 248m (814 ft)

Source: Wikipedia (state)

Job details above are provided by the employer/source. The sections on this page are compiled from public data sources with AI assistance.

Accommodations: if you need a workplace accommodation to apply for or perform this job, see ADA.gov or EEOC.gov for guidance on your rights and how to request one.

Add application deadline to calendar

Browse all jobs at Cagents →

Keep exploring on Get A Job.ai

Not quite the right fit? Your next opportunity is a click away.

Hiring instead? Post a job and reach candidates searching right now.

More jobs you might like