Validation Engineer
Waltham, MA · On-site
This role requires strong expertise in regulatory compliance, including GMP and 21 CFR Part 11, along with hands-on experience in equipment qualification and computerized system validation (CSV)
Validation Engineer
Waltham, MA · On-site
This role requires strong expertise in regulatory compliance, including GMP and 21 CFR Part 11, along with hands-on experience in equipment qualification and computerized system validation (CSV)
Perform 21 CFR Part 11 and EU Annex 11 gap assessment on existing scientific application software ... validation (IQ/OQ/PQ). Receive instructions on related assignments under general supervision. The ...
Perform 21 CFR Part 11 and EU Annex 11 gap assessment on existing scientific application software ... validation (IQ/OQ/PQ). Receive instructions on related assignments under general supervision. The ...
Validation Engineer 1 as 100% Remote
Sunnyvale, CA · Remote
$74/hr
Validation Engineer 1 Location: 100% Remote Duration: 03 Months Pay Rate: $60.00 - $74.00/- on W2 ... Good understanding of CSV, CSA, FDA regulations (21 CFR Part 11 & 820), GAMP5 & GxP regulations.
Quick apply
Validation Engineer 1 as 100% Remote
Sunnyvale, CA · Remote
$74/hr
Validation Engineer 1 Location: 100% Remote Duration: 03 Months Pay Rate: $60.00 - $74.00/- on W2 ... Good understanding of CSV, CSA, FDA regulations (21 CFR Part 11 & 820), GAMP5 & GxP regulations.
CQV Engineer
Austin, TX · On-site
Ensure compliance with 21 CFR Part 11 and ALCOA data integrity principles. * Support validation lifecycle documentation including protocols, test scripts, reports, deviations, and change controls.
CQV Engineer
Austin, TX · On-site
Ensure compliance with 21 CFR Part 11 and ALCOA data integrity principles. * Support validation lifecycle documentation including protocols, test scripts, reports, deviations, and change controls.
Perform 21 CFR Part 11 gap assessments for electronic records, electronic signatures, and audit ... Validate OPC/UA integration 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 integration between Metasys, AVEVA PI, and DeltaV QBMS. * Draft commissioning ...
Temporary, entry-level position to mitigate expected validation workload Review requirements ... 21 CFR Part 11 Electronic Records and Electronic Signatures Strong analytical, problem-solving ...
Temporary, entry-level position to mitigate expected validation workload Review requirements ... 21 CFR Part 11 Electronic Records and Electronic Signatures Strong analytical, problem-solving ...
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 ...
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... 21 CFR Part 11 electronic record requirements. * Execute the scanning and Veeva upload of ...
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Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... 21 CFR Part 11 electronic record requirements. * Execute the scanning and Veeva upload of ...
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... 21 CFR Part 11 electronic record requirements. * Execute the scanning and Veeva upload of ...
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... 21 CFR Part 11 electronic record requirements. * Execute the scanning and Veeva upload of ...
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 ...
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... 21 CFR Part 11 electronic record requirements. * Execute the scanning and Veeva upload of ...
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... 21 CFR Part 11 electronic record requirements. * Execute the scanning and Veeva upload of ...
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 ...
Quick apply
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 ...
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 ...
Ideal candidates have experience with 21 CFR Part 11 and EU Annexx 11, as well as have developed Quality Management Systems, authored GxP Validation Packages, and have had leadership roles. This role ...
Ideal candidates have experience with 21 CFR Part 11 and EU Annexx 11, as well as have developed Quality Management Systems, authored GxP Validation Packages, and have had leadership roles. This role ...
Ideal candidates have experience with 21 CFR Part 11 and EU Annexx 11, as well as have developed Quality Management Systems, authored GxP Validation Packages, and have had leadership roles. This role ...
Ideal candidates have experience with 21 CFR Part 11 and EU Annexx 11, as well as have developed Quality Management Systems, authored GxP Validation Packages, and have had leadership roles. This role ...
Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems Validation * Strong written and oral communication skills
Quick apply
Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems Validation * Strong written and oral communication skills
... 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 ...
Support GxP compliance, data integrity, and 21 CFR Part 11 considerations as applicable * Manage validation workstreams for both instruments simultaneously * Identify and escalate risks, gaps, delays ...
Support GxP compliance, data integrity, and 21 CFR Part 11 considerations as applicable * Manage validation workstreams for both instruments simultaneously * Identify and escalate risks, gaps, delays ...
Support GxP compliance, data integrity, and 21 CFR Part 11 considerations as applicable * Manage validation workstreams for both instruments simultaneously * Identify and escalate risks, gaps, delays ...
Quick apply
Support GxP compliance, data integrity, and 21 CFR Part 11 considerations as applicable * Manage validation workstreams for both instruments simultaneously * Identify and escalate risks, gaps, delays ...
Facilitate risk assessments for GxP computerized systems, ensuring compliance with 21 CFR Part 11, GAMP 5, and Data Integrity (ALCOA+) guidelines. Execute retrospective validation for legacy systems ...
Facilitate risk assessments for GxP computerized systems, ensuring compliance with 21 CFR Part 11, GAMP 5, and Data Integrity (ALCOA+) guidelines. Execute retrospective validation for legacy systems ...
Entry Level 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 entry level 21 cfr part 11 validation jobs pay per hour?
As of Aug 18, 2026, the average hourly pay for entry level 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 are the most commonly searched types of 21 Cfr Part 11 Validation jobs?
The most popular types of 21 Cfr Part 11 Validation jobs are:
What job categories do people searching Entry Level 21 Cfr Part 11 Validation jobs look for?
The top searched job categories for Entry Level 21 Cfr Part 11 Validation jobs are:
Other
Posted 4 days ago
Job description
Job Summary:
Experience:
- We are seeking a detail-oriented Validation Engineer to support validation and calibration activities for critical pharmaceutical manufacturing and sterile processing equipment.
- This role requires strong expertise in regulatory compliance, including GMP and 21 CFR Part 11, along with hands-on experience in equipment qualification and computerized system validation (CSV).
- Perform validation and calibration activities for pharmaceutical manufacturing and sterile processing equipment
- Ensure compliance with GMP and 21 CFR Part 11 standards
- Develop and execute Master Validation Plans, SOPs, and validation protocols for process validation (PPQ), aseptic processes, and cleaning/sterilization procedures
- Conduct equipment qualification activities (IQ/OQ/PQ) and ongoing performance monitoring
- Perform instrument calibration for equipment such as dual display light meters, open air shakers, and various scales
- Support validation of sterilization and cleaning systems, including CIP Skids, isolators, parts washers, and autoclaves
- Execute validation projects, ensuring timelines, budgets, and KPIs are met
- Collaborate with manufacturing, quality, and engineering teams to troubleshoot issues and resolve validation discrepancies
- Apply a risk-based approach to validation to ensure compliance and operational efficiency
- Coordinate resources and activities for complex validation and CSV initiatives
Experience:
- Experience in validation, calibration, or CQV within a pharmaceutical or regulated environment
- Strong knowledge of GMP and 21 CFR Part 11 compliance
- Proven experience with Computerized System Validation (CSV)
- Hands-on experience with IQ/OQ/PQ and validation lifecycle documentation
- Strong problem-solving, communication, and cross-functional collaboration skills