CSV Engineer
Somerset, NJ · On-site
... GxP, 21 CFR Part 11, and data integrity requirements throughout the system lifecycle • Support deviation investigations, CAPAs, and change control activities related to validated systems • ...
CSV Engineer
Somerset, NJ · On-site
... GxP, 21 CFR Part 11, and data integrity requirements throughout the system lifecycle • Support deviation investigations, CAPAs, and change control activities related to validated systems • ...
CSV Engineer
Somerset, NJ · On-site
... GxP, 21 CFR Part 11, and data integrity requirements throughout the system lifecycle • Support deviation investigations, CAPAs, and change control activities related to validated systems • ...
CSV Engineer
Somerset, NJ · On-site
... GxP, 21 CFR Part 11, and data integrity requirements throughout the system lifecycle • Support deviation investigations, CAPAs, and change control activities related to validated systems • ...
Project Manager
La Verne, CA · On-site
Perform GxP and 21 CFR part 11 assessments and develop validation plan. * Develop functional risk strategy and perform functional risk assessment. * Review user business process documents and user ...
Project Manager
La Verne, CA · On-site
Perform GxP and 21 CFR part 11 assessments and develop validation plan. * Develop functional risk strategy and perform functional risk assessment. * Review user business process documents and user ...
Senior Validation Analyst
Birmingham, AL · On-site
Senior Validation Analyst Southern Research + You Discover a career where your work truly matters ... This role requires strong knowledge of regulatory requirements and guidance (e.g., 21 CFR Part 11 ...
Senior Validation Analyst
Birmingham, AL · On-site
Senior Validation Analyst Southern Research + You Discover a career where your work truly matters ... This role requires strong knowledge of regulatory requirements and guidance (e.g., 21 CFR Part 11 ...
Perform 21 CFR Part 11 gap assessments for electronic records, electronic signatures, and audit ... Validate OPC UA integrations between Metasys, AVEVA PI, and DeltaV QBMS. Draft commissioning ...
Perform 21 CFR Part 11 gap assessments for electronic records, electronic signatures, and audit ... Validate OPC UA integrations between Metasys, AVEVA PI, and DeltaV QBMS. Draft commissioning ...
Validation Specialist
Marion, NC · On-site
Validation Specialist Marion, NC, USA 12 months W2 contract Must have experience supporting medical device manufacturing under ISO 13485 Writing test protocols within KNEAT Gx Knowledge of CQV ...
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Validation Specialist
Marion, NC · On-site
Validation Specialist Marion, NC, USA 12 months W2 contract Must have experience supporting medical device manufacturing under ISO 13485 Writing test protocols within KNEAT Gx Knowledge of CQV ...
Evaluate systems against FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, ALCOA+ data-integrity principles, and other applicable regulatory expectations. * Validate controls covering ...
Evaluate systems against FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, ALCOA+ data-integrity principles, and other applicable regulatory expectations. * Validate controls covering ...
Technical Test Lead | Infrastructure Security | Infrastructure Security - ALL
Bedford, MA · On-site
$150K/yr
Ensure compliance with GMP & FDA 21 CFR Part 11 (audit trails, electronic records, RBAC). Support Computer System Validation (CSV) documentation (URS/NFR/FS/DS/IQ/OQ/PQ). Define patch management and ...
Technical Test Lead | Infrastructure Security | Infrastructure Security - ALL
Bedford, MA · On-site
$150K/yr
Ensure compliance with GMP & FDA 21 CFR Part 11 (audit trails, electronic records, RBAC). Support Computer System Validation (CSV) documentation (URS/NFR/FS/DS/IQ/OQ/PQ). Define patch management and ...
Associate Director (Multiple Positions) | ZR_880_JOB
Westlake Village, CA · On-site
$160K/yr
Designing DocuSign-based electronic signature architectures in alignment with 21 CFR Part 11 through the application of standardized configuration and validation methodologies; Engineering governed ...
Associate Director (Multiple Positions) | ZR_880_JOB
Westlake Village, CA · On-site
$160K/yr
Designing DocuSign-based electronic signature architectures in alignment with 21 CFR Part 11 through the application of standardized configuration and validation methodologies; Engineering governed ...
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 ...
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 ...
Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems Validation * Strong written and oral communication skills
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Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems Validation * Strong written and oral communication skills
CQV/Validation Engineer
Holbrook, MA · On-site
$33 - $43/hr
Knowledge of 21 CFR Part 11, validation lifecycle principles, or risk-based validation approaches preferred. * Auto CAD experience preferred. * Flexible to work overtime (paid) as needed. Pay Range ...
CQV/Validation Engineer
Holbrook, MA · On-site
$33 - $43/hr
Knowledge of 21 CFR Part 11, validation lifecycle principles, or risk-based validation approaches preferred. * Auto CAD experience preferred. * Flexible to work overtime (paid) as needed. Pay Range ...
Own and maintain Nurix's Computer Systems Assurance policy framework, SOPs, and risk-based validation strategy, aligned with FDA CSA guidance (2022), GAMP 5 (2nd edition), 21 CFR Part 11, EU Annex 11 ...
Own and maintain Nurix's Computer Systems Assurance policy framework, SOPs, and risk-based validation strategy, aligned with FDA CSA guidance (2022), GAMP 5 (2nd edition), 21 CFR Part 11, EU Annex 11 ...
... 21 CFR Part 11 Assessment Data Migration Qualification Disaster Recovery Qualification Qualification and Commission Validation coverage in IQ, OQ and PQ Deviation management process CAPA Validation ...
... 21 CFR Part 11 Assessment Data Migration Qualification Disaster Recovery Qualification Qualification and Commission Validation coverage in IQ, OQ and PQ Deviation management process CAPA Validation ...
(Sr.) Validation Engineer
$80K - $120K/yr
Prepare validation documentation in accordance with cGMP, FDA, EU GMP, GAMP 5, and 21 CFR Part 11 requirements. * Support deviation investigations, CAPAs, change controls, and risk assessments ...
(Sr.) Validation Engineer
$80K - $120K/yr
Prepare validation documentation in accordance with cGMP, FDA, EU GMP, GAMP 5, and 21 CFR Part 11 requirements. * Support deviation investigations, CAPAs, change controls, and risk assessments ...
Urgent On-Site Opening for Senior CSV Engineer - Needham, MA - Need Local to MA Only.
Needham, MA · On-site
$113K - $156K/yr
Strong knowledge of 21 CFR Part 11, EU Annex 11, data integrity, and GAMP 5. * Proven experience validating EMS, BMS, and laboratory informatics/data systems. * Proficiency in authoring and executing ...
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Urgent On-Site Opening for Senior CSV Engineer - Needham, MA - Need Local to MA Only.
Needham, MA · On-site
$113K - $156K/yr
Strong knowledge of 21 CFR Part 11, EU Annex 11, data integrity, and GAMP 5. * Proven experience validating EMS, BMS, and laboratory informatics/data systems. * Proficiency in authoring and executing ...
Validation Expert
Fort Worth, TX · On-site
Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR Part 11, GxP, GAMP 5, Data Privacy, Data Integrity and Information Security * Develop and ...
Validation Expert
Fort Worth, TX · On-site
Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR Part 11, GxP, GAMP 5, Data Privacy, Data Integrity and Information Security * Develop and ...
Strong knowledge of 21 CFR Part 11 and EU Annex 11; ALCOA+ data integrity principles. * Experience validating SDLC/CSV across system types (e.g., LIMS, MES, QMS, ERP, DMS, Lab instruments, cloud/SaaS ...
Quick apply
Strong knowledge of 21 CFR Part 11 and EU Annex 11; ALCOA+ data integrity principles. * Experience validating SDLC/CSV across system types (e.g., LIMS, MES, QMS, ERP, DMS, Lab instruments, cloud/SaaS ...
Description The Quality Systems Engineer will develop and execute regulated non-product software systems validation in accordance with applicable regulatory standards (e.g., FDA 21 CFR Part 11, ISO ...
Description The Quality Systems Engineer will develop and execute regulated non-product software systems validation in accordance with applicable regulatory standards (e.g., FDA 21 CFR Part 11, ISO ...
Sr. CSV/CQV Specialist
Raritan, NJ · On-site
Executes the commissioning, qualification, requalification, validation and any associated ... Expertise in GMP compliance knowledge including knowledge of 21 CFR Part 11, EU Annex 11 among ...
Sr. CSV/CQV Specialist
Raritan, NJ · On-site
Executes the commissioning, qualification, requalification, validation and any associated ... Expertise in GMP compliance knowledge including knowledge of 21 CFR Part 11, EU Annex 11 among ...
21 Cfr Part 11 Validation information
See salary details
$22.60 - $27.64
2% of jobs
$27.64 - $32.69
6% of jobs
$32.69 - $37.74
13% of jobs
$39.32 is the 25th percentile. Wages below this are outliers.
$37.74 - $42.79
13% of jobs
$42.79 - $47.84
11% of jobs
The median wage is $50.36 / hr.
$47.84 - $52.88
12% of jobs
$52.88 - $57.93
9% of jobs
$61.82 is the 75th percentile. Wages above this are outliers.
$57.93 - $62.98
13% of jobs
$62.98 - $68.03
13% of jobs
$68.03 - $73.08
6% of jobs
$73.08 - $78.13
3% of jobs
$22
$51
$78
How much do 21 cfr part 11 validation jobs pay per hour?
As of Sep 3, 2026, the average hourly pay for 21 cfr part 11 validation in the United States is $52.00, according to ZipRecruiter salary data. Most workers in this role earn between $39.42 and $63.22 per hour, depending on experience, location, and employer.
What is 21 CFR Part 11 Validation?
A 21 CFR Part 11 Validation job involves ensuring that electronic records and signatures comply with FDA regulations for reliability, security, and data integrity. Professionals in this role validate computer systems, software, and processes used in regulated industries like pharmaceuticals and biotechnology. They create and execute validation protocols, conduct risk assessments, and document compliance efforts. Their work helps organizations meet regulatory requirements and avoid issues related to electronic data integrity.
What skills and qualifications are needed for 21 CFR Part 11 Validation?
To thrive in a 21 CFR Part 11 Validation role, you need in-depth knowledge of FDA regulations, validation protocols, and quality compliance standards, often supported by a degree in life sciences, engineering, or a related field. Experience with computerized systems validation (CSV) tools, risk management methodologies, and familiarity with common validation documentation systems is highly valuable, and certifications such as ASQ or PMP can be an advantage. Strong analytical thinking, attention to detail, and effective communication skills are crucial for preparing documentation and collaborating with cross-functional teams. These capabilities enable accurate validation processes, ensure regulatory compliance, and minimize risks in regulated environments.
What are the common challenges faced in 21 CFR Part 11 Validation?
One of the common challenges in a 21 CFR Part 11 Validation role is keeping up with evolving regulatory requirements while ensuring all computerized systems meet compliance standards. You'll often need to manage multiple projects simultaneously, coordinate with IT, QA, and production teams, and address any gaps in existing processes or documentation. Additionally, troubleshooting integration issues between systems and maintaining meticulous records can require both technical expertise and organized workflows. Overcoming these challenges not only enhances your problem-solving skills but also strengthens your value as a validation professional.
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States with the most job openings for 21 Cfr Part 11 Validation jobs include:
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Full-time
Re-posted 13 days ago
Job description
Job Summary:
Katalyst CRO is a company focused on providing services in the life sciences sector, and they are seeking an IT CSV Validation Engineer. This role is responsible for authoring and executing validation test scripts for regulated systems, ensuring compliance with regulatory requirements and data integrity standards in GxP environments.
Responsibilities:
• Author, review, and execute validation test scripts (IQ/OQ/PQ) for GxP computerized systems
• Support validation activities for ERP Master Data Governance processes, ensuring data accuracy, integrity, and compliance
• Perform validation of Data Lake platforms and associated system interfaces, including data ingestion, transformation, and reporting layers
• Collaborate with cross-functional teams (IT, QA, Business, Data Engineering) to define validation scope, risk assessments, and acceptance criteria
• Ensure compliance with GxP, 21 CFR Part 11, and data integrity requirements throughout the system lifecycle
• Support deviation investigations, CAPAs, and change control activities related to validated systems
• Maintain validation documentation including Validation Plans, Risk Assessments, Traceability Matrices, and Summary Reports
Qualifications:
Required:
• Bachelor's degree in Computer Science, Engineering, Life Sciences, or related discipline
• 5+ years of Computer System Validation (CSV) experience in pharmaceutical or life sciences environments
• Strong experience with test script authoring and execution for GxP systems
• Experience supporting Master Data Governance processes
• Experience validating Data Lake environments and system interfaces
• Strong understanding of GxP, 21 CFR Part 11, and data integrity principles
• Ability to work independently and manage multiple validation activities with minimal oversight
Preferred:
• SAP experience preferred but not required
• Snowflake experience preferred
• Familiarity with AI/advanced data platforms is a plus
• Experience with validation management tools such as Val Genesis is a plus
Company:
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide. Founded in , the company is headquartered in South Plainfield, USA, with a team of 51-200 employees. The company is currently Growth Stage.
Katalyst CRO is a company focused on providing services in the life sciences sector, and they are seeking an IT CSV Validation Engineer. This role is responsible for authoring and executing validation test scripts for regulated systems, ensuring compliance with regulatory requirements and data integrity standards in GxP environments.
Responsibilities:
• Author, review, and execute validation test scripts (IQ/OQ/PQ) for GxP computerized systems
• Support validation activities for ERP Master Data Governance processes, ensuring data accuracy, integrity, and compliance
• Perform validation of Data Lake platforms and associated system interfaces, including data ingestion, transformation, and reporting layers
• Collaborate with cross-functional teams (IT, QA, Business, Data Engineering) to define validation scope, risk assessments, and acceptance criteria
• Ensure compliance with GxP, 21 CFR Part 11, and data integrity requirements throughout the system lifecycle
• Support deviation investigations, CAPAs, and change control activities related to validated systems
• Maintain validation documentation including Validation Plans, Risk Assessments, Traceability Matrices, and Summary Reports
Qualifications:
Required:
• Bachelor's degree in Computer Science, Engineering, Life Sciences, or related discipline
• 5+ years of Computer System Validation (CSV) experience in pharmaceutical or life sciences environments
• Strong experience with test script authoring and execution for GxP systems
• Experience supporting Master Data Governance processes
• Experience validating Data Lake environments and system interfaces
• Strong understanding of GxP, 21 CFR Part 11, and data integrity principles
• Ability to work independently and manage multiple validation activities with minimal oversight
Preferred:
• SAP experience preferred but not required
• Snowflake experience preferred
• Familiarity with AI/advanced data platforms is a plus
• Experience with validation management tools such as Val Genesis is a plus
Company:
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide. Founded in , the company is headquartered in South Plainfield, USA, with a team of 51-200 employees. The company is currently Growth Stage.