Experience/ exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5. * Experience of CSV Validation in any one of the Lab systems is must. * Should worked in ...
Experience/ exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5. * Experience of CSV Validation in any one of the Lab systems is must. * Should worked in ...
CSV Specialist
Gurabo, PR · On-site
... validation lifecycle, ensuring compliance with FDA, cGMP, 21 CFR Part 11, GAMP 5, and corporate standards. This position will support system implementations, upgrades, and periodic reviews across ...
CSV Specialist
Gurabo, PR · On-site
... validation lifecycle, ensuring compliance with FDA, cGMP, 21 CFR Part 11, GAMP 5, and corporate standards. This position will support system implementations, upgrades, and periodic reviews across ...
Ensure that the system is installed and configured in a 21 CFR Part 11/Annex 11 compliant manner. Provide validation expertise and support to the Quality Control laboratories. At least 4 years ...
Ensure that the system is installed and configured in a 21 CFR Part 11/Annex 11 compliant manner. Provide validation expertise and support to the Quality Control laboratories. At least 4 years ...
CSV Specialist
Gurabo, PR · On-site
$65 - $90/hr
... validation lifecycle, ensuring compliance with FDA, cGMP, 21 CFR Part 11, GAMP 5, and corporate standards. This position will support system implementations, upgrades, and periodic reviews across ...
CSV Specialist
Gurabo, PR · On-site
$65 - $90/hr
... validation lifecycle, ensuring compliance with FDA, cGMP, 21 CFR Part 11, GAMP 5, and corporate standards. This position will support system implementations, upgrades, and periodic reviews across ...
Ensure compliance with relevant standards (e.g., FDA 21 CFR Part 11, ISO 13485, GAMP 5). * Support audits and inspections by providing validation documentation. * Test Planning and Design * Develop ...
Quick apply
Ensure compliance with relevant standards (e.g., FDA 21 CFR Part 11, ISO 13485, GAMP 5). * Support audits and inspections by providing validation documentation. * Test Planning and Design * Develop ...
Computer System Validation (CSV) Specialist (EBR System)
Barceloneta, PR · On-site
$90 - $150/hr
Validate and support the Electronic Batch Record / EVRS implementation so it meets 21 CFR Part 11, EU GMP Annex 11, GxP, and company quality requirements. Scope of work * Develop/execute CSV ...
Computer System Validation (CSV) Specialist (EBR System)
Barceloneta, PR · On-site
$90 - $150/hr
Validate and support the Electronic Batch Record / EVRS implementation so it meets 21 CFR Part 11, EU GMP Annex 11, GxP, and company quality requirements. Scope of work * Develop/execute CSV ...
Director, Validation
Brighton, MI · On-site
$100K - $120K/yr
Establish and oversee the Computer Systems Validation program, including application of GAMP 5, data integrity principles, electronic records/signatures requirements, and 21 CFR Part 11.Provide ...
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Director, Validation
Brighton, MI · On-site
$100K - $120K/yr
Establish and oversee the Computer Systems Validation program, including application of GAMP 5, data integrity principles, electronic records/signatures requirements, and 21 CFR Part 11.Provide ...
Ensure compliance with GxP, Computer System Validation (CSV/CSA), 21 CFR Part 11, ALCOA+ principles, and data integrity requirements. * Serve as the primary escalation point for testing, validation ...
Ensure compliance with GxP, Computer System Validation (CSV/CSA), 21 CFR Part 11, ALCOA+ principles, and data integrity requirements. * Serve as the primary escalation point for testing, validation ...
Ensure compliance with GxP, Computer System Validation (CSV/CSA), 21 CFR Part 11, ALCOA+ principles, and data integrity requirements. * Serve as the primary escalation point for testing, validation ...
Ensure compliance with GxP, Computer System Validation (CSV/CSA), 21 CFR Part 11, ALCOA+ principles, and data integrity requirements. * Serve as the primary escalation point for testing, validation ...
Ensure compliance with GxP, Computer System Validation (CSV/CSA), 21 CFR Part 11, ALCOA+ principles, and data integrity requirements. * Serve as the primary escalation point for testing, validation ...
Ensure compliance with GxP, Computer System Validation (CSV/CSA), 21 CFR Part 11, ALCOA+ principles, and data integrity requirements. * Serve as the primary escalation point for testing, validation ...
Ensure compliance with GxP, Computer System Validation (CSV/CSA), 21 CFR Part 11, ALCOA+ principles, and data integrity requirements. * Serve as the primary escalation point for testing, validation ...
Ensure compliance with GxP, Computer System Validation (CSV/CSA), 21 CFR Part 11, ALCOA+ principles, and data integrity requirements. * Serve as the primary escalation point for testing, validation ...
Ensure compliance with GxP, Computer System Validation (CSV/CSA), 21 CFR Part 11, ALCOA+ principles, and data integrity requirements. * Serve as the primary escalation point for testing, validation ...
Ensure compliance with GxP, Computer System Validation (CSV/CSA), 21 CFR Part 11, ALCOA+ principles, and data integrity requirements. * Serve as the primary escalation point for testing, validation ...
Ensure compliance with GxP, Computer System Validation (CSV/CSA), 21 CFR Part 11, ALCOA+ principles, and data integrity requirements. * Serve as the primary escalation point for testing, validation ...
Ensure compliance with GxP, Computer System Validation (CSV/CSA), 21 CFR Part 11, ALCOA+ principles, and data integrity requirements. * Serve as the primary escalation point for testing, validation ...
Ensure compliance with GxP, Computer System Validation (CSV/CSA), 21 CFR Part 11, ALCOA+ principles, and data integrity requirements. * Serve as the primary escalation point for testing, validation ...
Ensure compliance with GxP, Computer System Validation (CSV/CSA), 21 CFR Part 11, ALCOA+ principles, and data integrity requirements. * Serve as the primary escalation point for testing, validation ...
Ensure compliance with GxP, Computer System Validation (CSV/CSA), 21 CFR Part 11, ALCOA+ principles, and data integrity requirements. * Serve as the primary escalation point for testing, validation ...
Ensure compliance with GxP, Computer System Validation (CSV/CSA), 21 CFR Part 11, ALCOA+ principles, and data integrity requirements. * Serve as the primary escalation point for testing, validation ...
Ensure compliance with GxP, Computer System Validation (CSV/CSA), 21 CFR Part 11, ALCOA+ principles, and data integrity requirements. * Serve as the primary escalation point for testing, validation ...
Ensure compliance with GxP, Computer System Validation (CSV/CSA), 21 CFR Part 11, ALCOA+ principles, and data integrity requirements. * Serve as the primary escalation point for testing, validation ...
Ensure compliance with GxP, Computer System Validation (CSV/CSA), 21 CFR Part 11, ALCOA+ principles, and data integrity requirements. * Serve as the primary escalation point for testing, validation ...
Ensure compliance with GxP, Computer System Validation (CSV/CSA), 21 CFR Part 11, ALCOA+ principles, and data integrity requirements. * Serve as the primary escalation point for testing, validation ...
Ensure compliance with GxP, Computer System Validation (CSV/CSA), 21 CFR Part 11, ALCOA+ principles, and data integrity requirements. * Serve as the primary escalation point for testing, validation ...
Ensure compliance with GxP, Computer System Validation (CSV/CSA), 21 CFR Part 11, ALCOA+ principles, and data integrity requirements. * Serve as the primary escalation point for testing, validation ...
Ensure compliance with GxP, Computer System Validation (CSV/CSA), 21 CFR Part 11, ALCOA+ principles, and data integrity requirements. * Serve as the primary escalation point for testing, validation ...
Ensure compliance with GxP, Computer System Validation (CSV/CSA), 21 CFR Part 11, ALCOA+ principles, and data integrity requirements. * Serve as the primary escalation point for testing, validation ...
Ensure compliance with GxP, Computer System Validation (CSV/CSA), 21 CFR Part 11, ALCOA+ principles, and data integrity requirements. * Serve as the primary escalation point for testing, validation ...
Ensure compliance with GxP, Computer System Validation (CSV/CSA), 21 CFR Part 11, ALCOA+ principles, and data integrity requirements. * Serve as the primary escalation point for testing, validation ...
Intern 21 Cfr Part 11 Validation information
What is the difference between Intern 21 Cfr Part 11 Validation vs Quality Assurance Intern?
| Aspect | Intern 21 Cfr Part 11 Validation | Quality Assurance Intern |
|---|---|---|
| Certifications | Knowledge of 21 CFR Part 11 regulations, validation protocols | Understanding of QA processes, industry standards |
| Work Environment | Regulatory compliance, validation testing in regulated labs | Quality control, process audits in manufacturing or labs |
| Employer & Industry | Pharmaceutical, biotech, or medical device companies | Pharmaceutical, biotech, or manufacturing sectors |
Intern 21 Cfr Part 11 Validation focuses on ensuring electronic records and signatures comply with FDA regulations, involving validation protocols. Quality Assurance Interns concentrate on overall quality processes, audits, and standards. While both roles support compliance and quality, the validation role is more specialized in regulatory validation tasks, whereas QA interns handle broader quality assurance activities.
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Full-time
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Re-posted 3 days ago
Cognizant rating
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Based on 87 frontline employees who took The Breakroom Quiz
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Job description
Job Details:
Testing (in addition to above)
*Please note this role is not able to offer visa transfer or sponsorship now or in the future*
We're excited to meet people who share our mission and who can make an impact in a variety of ways. Don't hesitate to apply-even if you only meet the minimum requirements. Think about your transferable experiences and unique skills that make you stand out.
Salary and Other Compensation:
Applications will be accepted until Aug 30, 2026,
The annual salary for this position is between $ 75,000 - $ 123,000 depending on experience and other qualifications of the successful candidate.
This position is also eligible for Cognizant's discretionary annual incentive program, based on performance and subject to the terms of Cognizant's applicable plans.
Benefits: Cognizant offers the following benefits for this position, subject to applicable eligibility requirements:
Disclaimer: The salary, other compensation, and benefits information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.
About Cognizant:
Cognizant (Nasdaq: CTSH) is an AI Builder and technology services provider, bridging the gap between AI investment and enterprise value by building full-stack AI solutions for our clients. Our deep industry, process and engineering expertise enables us to build an organization's unique context into technology systems that amplify human potential, drive tangible outcomes and keep global enterprises ahead in a fast-changing world. See how at cognizant.ai or @cognizant.
Additional employment information
Compensation information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.
Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.
Cognizant is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.
If you have a disability that requires reasonable accommodation to search for a job opening or submit an application, please email [email protected] for roles based in the Americas or [email protected] for roles based in India.
- Experience/ exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.
- Experience of CSV Validation in any one of the Lab systems is must.
- Should worked in pharmaceutical domain and its related knowledge is must
- Good communication and technical writing skills are a must
- Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP environments.
- Project Deliverables will encompass validation plans, specifications, test protocols and standard operation procedures and systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure.
- CSV, GAMP 5 CPFR Part 11, Validation, Worked in V model, SOP & SDLC Lifecycle. Adaptation of CSA and Module Validation is preferred.
- To provide a planned approach for the implementation of the CSV deliverables, migration due diligence, GXP and Non GXP areas
- Provide guidance and leadership regarding Regulatory Compliance and Quality Management requirement.
- Prepare and execute URS, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, Traceability Matrix etc.
- Exposure to Regulatory Audits and Remediation activities
- Ensure the CSV artefacts are in line and meets regulatory requirements
- Preferred Experience in Agile Development
- Knowledge on working in Jira / Service Now
- Adaptation to AI is preferred.
Testing (in addition to above)
- Experience in testing and knowledge in any one of the QC/R&D Lab systems is must.
- Prepare and execute TP, IQ, OQ, PQ, TSR, Traceability Matrix etc is must.
- Knowledge on working in Jira, HP ALM or any automation testing tools.
*Please note this role is not able to offer visa transfer or sponsorship now or in the future*
We're excited to meet people who share our mission and who can make an impact in a variety of ways. Don't hesitate to apply-even if you only meet the minimum requirements. Think about your transferable experiences and unique skills that make you stand out.
Salary and Other Compensation:
Applications will be accepted until Aug 30, 2026,
The annual salary for this position is between $ 75,000 - $ 123,000 depending on experience and other qualifications of the successful candidate.
This position is also eligible for Cognizant's discretionary annual incentive program, based on performance and subject to the terms of Cognizant's applicable plans.
Benefits: Cognizant offers the following benefits for this position, subject to applicable eligibility requirements:
- Medical/Dental/Vision/Life Insurance
- Paid holidays plus Paid Time Off
- 401(k) plan and contributions
- Long-term/Short-term Disability
- Paid Parental Leave
- Employee Stock Purchase Plan
Disclaimer: The salary, other compensation, and benefits information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.
About Cognizant:
Cognizant (Nasdaq: CTSH) is an AI Builder and technology services provider, bridging the gap between AI investment and enterprise value by building full-stack AI solutions for our clients. Our deep industry, process and engineering expertise enables us to build an organization's unique context into technology systems that amplify human potential, drive tangible outcomes and keep global enterprises ahead in a fast-changing world. See how at cognizant.ai or @cognizant.
Additional employment information
Compensation information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.
Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.
Cognizant is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.
If you have a disability that requires reasonable accommodation to search for a job opening or submit an application, please email [email protected] for roles based in the Americas or [email protected] for roles based in India.
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