Framingham, MA · On-site
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 ...
Framingham, MA · On-site
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 ...
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.
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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.
The firm provides subject matter expertise in compliance with 21 CFR Part 11 and Annex 11 ... Its primary focus is helping life science companies successfully implement, validate, and manage ...
The firm provides subject matter expertise in compliance with 21 CFR Part 11 and Annex 11 ... Its primary focus is helping life science companies successfully implement, validate, and manage ...
... FDA 21 CFR Part 11 and Annex 11, MHRA Data Integrity. Validation documentation includes ... specifications, protocols, reports and risk assessments. * Direct validation activities; including ...
... FDA 21 CFR Part 11 and Annex 11, MHRA Data Integrity. Validation documentation includes ... specifications, protocols, reports and risk assessments. * Direct validation activities; including ...
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 ...
San Diego, CA · On-site
Knowledge of FDA 21 CFR 820.30, 21 CFR 820.70, 21 CFR Part 11, ISO 13485, ISO 14971, cGMP, GDP, and Design Control. * Experience with validation of IVD lab equipment such as PCR systems, freezers ...
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San Diego, CA · On-site
Knowledge of FDA 21 CFR 820.30, 21 CFR 820.70, 21 CFR Part 11, ISO 13485, ISO 14971, cGMP, GDP, and Design Control. * Experience with validation of IVD lab equipment such as PCR systems, freezers ...
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 approaches. • Maintain and manage Audit Trails, electronic signature configurations, and user access controls on all 21 CFR Part 11-regulated systems, ensuring records meet ALCOA ...
... validation approaches. • Maintain and manage Audit Trails, electronic signature configurations, and user access controls on all 21 CFR Part 11-regulated systems, ensuring records meet ALCOA ...
... validation approaches. • Maintain and manage Audit Trails, electronic signature configurations, and user access controls on all 21 CFR Part 11-regulated systems, ensuring records meet ALCOA ...
... validation approaches. • Maintain and manage Audit Trails, electronic signature configurations, and user access controls on all 21 CFR Part 11-regulated systems, ensuring records meet ALCOA ...
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 ...
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 ...
... 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 ...
... validation approaches. * Maintain and manage Audit Trails, electronic signature configurations, and user access controls on all 21 CFR Part 11-regulated systems, ensuring records meet ALCOA ...
... validation approaches. * Maintain and manage Audit Trails, electronic signature configurations, and user access controls on all 21 CFR Part 11-regulated systems, ensuring records meet ALCOA ...
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 ...
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 ...
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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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 ...
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 ...
$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
Contractor
Posted 16 days ago
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Title: Validation Specialist III
Location: Framingham, MA
Duration: 8 Months (Possible Extension)
Job Responsibilities:
Perform validation (IQ, OQ, PQ) of various types of equipment and systems including validation or requalification of temperature controlled chambers and lab equipment.
This would include refrigerators, cold rooms, freezers, incubators, liquid N2, etc.
Write and execute validation protocols and write validation reports including thorough resolution of protocol deviations or non-conformances.
Investigate/troubleshoot validation problems or issues; conduct statistical analysis of testing results.
Perform 21 CFR Part 11 and EU Annex 11 gap assessment on existing scientific application software that is being used in laboratories. Develop 21 CFR Part 11 and EU Annex 11 compliance plan.
Assess compatibility of instrument software with existing windows operating system.
Collaborate with instrument software vendors to execute 21 CFR Part 11 and EU Annex 11 compliance plan including preparation of user requirement specifications (URS) and functional specifications, GxP impact assessment, risk assessment and validation (IQ/OQ/PQ).
Receive instructions on related assignments under general supervision.
The position will report to Manager, Quality Process Analysis with a dotted line to the Manager, R&D Validation.
Qualification:
Experience or familiarity with applicable US and worldwide regulatory requirements for the biotechnology industry (EU Annex 11, 21CFR Part 11, etc.).
Demonstrated knowledge of GMP regulations and good documentation practices is required.
Familiarity with application software such as Waters MassLynx, Beckman-Coulter 32 Karat, Applied Biosystems 7500 SDS, Molecular Devices Softmax Pro, Gage InSite, TrackWise, etc.
Proficiency with MS Word, MS Excel, MS Access, MS PowerPoint, MS Project.
Experience with Microsoft Word, Excel, Project, and Visio.
All your information will be kept confidential according to EEO guidelines.
Sourced by ZipRecruiter
Artech is a leading IT staffing and consulting company based in Morristown, NJ, US. Since its foundation in 1992, Artech has mastered in complementing human expertise with technology and business acumen to produce world-class staffing solutions. The company caters to diverse industry sectors, including financial services, healthcare, telecommunication, energy and utilities, supply chain, and retail. It provides IT consulting, project management, professional and staff augmentation, and managed staffing services. Artech's mission is to provide exceptional IT staffing services to its clients by comprehending their business needs and then crafting a customized staffing strategy. Its notable achievement includes being recognized as one of the largest IT staffing companies in the U.S, according to Staffing Industry Analysts (SIA).
Recruiting and staffing services
10,000+ Employees
Morristown, NJ, US
1992
