companyCAI logo

Computer Systems Validation Engineer

CAIRockville, Maryland
On-site Full-time

Clicking Apply Now takes you to AutoApply where you can tailor your resume and apply.


Unlock Your Potential

Generate Job-Optimized Resume

One Click And Our AI Optimizes Your Resume to Match The Job Description.

Is Your Resume Optimized For This Role?

Find Out If You're Highlighting The Right Skills And Fix What's Missing

Experience Level

Experience

Qualifications

Essential Duties and ResponsibilitiesDocumentation & ComplianceDraft GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports)Create and execute test protocols and scriptsEnsure compliance with 21 CFR Part 11 and data integrity standardsReview and contribute to validation plans and risk assessmentsSystem & Industry ProficiencyAssist with CSV activities across diverse platforms including MES, DCS, SCADA, and batch systemsWork with major systems and platforms such as Rockwell PharmaSuite, Rockwell Automation, Emerson DeltaV, DeltaV Batch, Emerson Syncade, PI, GE, ABB, Siemens, Honeywell, PAS-X, FactoryTalk, FactoryLogix, PLM, Simatic, iFix, WonderwareLeverage understanding of GAMP guidelines and compliance requirements (21 CFR Parts 210, 211, 11)Utilize knowledge of S88/S95 batch control standardsClient Engagement & Technical ExecutionSupport client interactions with a strong customer service orientationConduct system assessments and address data integrity issuesCollaborate with client teams to ensure validation compliance and successful project delivery

About the job

Are You Ready to Elevate Your Career?
CAI is a dynamic, 100% employee-owned professional services firm founded in 1996, boasting a global workforce of over 700 professionals. We specialize in commissioning, qualification, validation, and startup services, along with project management and consulting tailored for FDA-regulated and mission-critical sectors.
Our philosophy is straightforward—we prioritize our clients' needs, relentlessly pursue excellence, and are committed to achieving the best outcomes.

Our Core Values:
- Integrity in all actions
- Commitment to serving one another
- Dedication to societal benefit
- Focused on future growth

As an employee-owned company, your success directly contributes to our collective achievements. We strive to meet our team objectives while embodying our core principles:
- Team First
- Respect for Individuals
- Positive Attitude

This position can be based in Rockville, MD or Frederick, MD

About CAI

At CAI, we pride ourselves on our employee ownership structure that empowers our professionals and drives our collective success. Our commitment to integrity and service excellence positions us as a trusted partner in the life sciences industry.

Similar jobs

Tailoring 0 resumes

We'll move completed jobs to Ready to Apply automatically.