Our Computer Systems Validation Leads work directly with our clients to support activities that ... CSV including 21 CFR Part 11 * Strong knowledge of computerized system development life cycle ...
Our Computer Systems Validation Leads work directly with our clients to support activities that ... CSV including 21 CFR Part 11 * Strong knowledge of computerized system development life cycle ...
Computer Systems Validation Engineer
Rockville, MD · On-site
$75K - $106K/yr
... computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test ... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ...
Quick apply
Computer Systems Validation Engineer
Rockville, MD · On-site
$75K - $106K/yr
... computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test ... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ...
Computer Systems Validation Engineer
$75K - $106K/yr
... computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test ... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ...
Computer Systems Validation Engineer
$75K - $106K/yr
... computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test ... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ...
GMP IT Infrastructure and System (Sr) Engineer
Rockville, MD · On-site
$94K - $151K/yr
Provide IT support for computer system validation (CSV) to ensure data integrity per FDA regulation. * Works with Quality department to present change plans, change actions, and close assigned ...
Quick apply
GMP IT Infrastructure and System (Sr) Engineer
Rockville, MD · On-site
$94K - $151K/yr
Provide IT support for computer system validation (CSV) to ensure data integrity per FDA regulation. * Works with Quality department to present change plans, change actions, and close assigned ...
GMP IT Infrastructure and System (Sr) Engineer
Rockville, MD · On-site
$94K - $151K/yr
Provide IT support for computer system validation (CSV) to ensure data integrity per FDA regulation. * Works with Quality department to present change plans, change actions, and close assigned ...
Quick apply
GMP IT Infrastructure and System (Sr) Engineer
Rockville, MD · On-site
$94K - $151K/yr
Provide IT support for computer system validation (CSV) to ensure data integrity per FDA regulation. * Works with Quality department to present change plans, change actions, and close assigned ...
Senior IT Associate-Quality Assurance Specialist (Contingent)
Bethesda, MD · On-site
$88K - $121K/yr
Develop and maintain Computer Systems Validation (CSV) / Computer Systems Assurance (CSA) documentation, including Validation Plans, Installation Qualification (IQ), Operational Qualification (OQ ...
Senior IT Associate-Quality Assurance Specialist (Contingent)
Bethesda, MD · On-site
$88K - $121K/yr
Develop and maintain Computer Systems Validation (CSV) / Computer Systems Assurance (CSA) documentation, including Validation Plans, Installation Qualification (IQ), Operational Qualification (OQ ...
Associate Director Senior Data Analyst (Clinical Sciences)
Gaithersburg, MD · On-site +1
$146K - $234K/yr
Coordinate service operations and SLA compliance, support Computer System Validation (CSV) and GxP processes * Maintain validation documentation (URS, IQ/OQ/PQ, traceability, reports) and ensure ...
Associate Director Senior Data Analyst (Clinical Sciences)
Gaithersburg, MD · On-site +1
$146K - $234K/yr
Coordinate service operations and SLA compliance, support Computer System Validation (CSV) and GxP processes * Maintain validation documentation (URS, IQ/OQ/PQ, traceability, reports) and ensure ...
System Test and Validation Lead
Rosslyn, VA · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Rosslyn, VA · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Mclean, VA · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Mclean, VA · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Rosslyn, VA · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Rosslyn, VA · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Mclean, VA · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Mclean, VA · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Rosslyn, VA · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Rosslyn, VA · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Mclean, VA · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Mclean, VA · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Washington, DC · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Washington, DC · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Washington, DC · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Washington, DC · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Washington, DC · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Washington, DC · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
Automation SME
Gaithersburg, MD · On-site
... system validation (CSV), and data integrity principles. · Experience leading automation system design, commissioning, qualification, troubleshooting, and lifecycle support. · Excellent ...
New
Automation SME
Gaithersburg, MD · On-site
... system validation (CSV), and data integrity principles. · Experience leading automation system design, commissioning, qualification, troubleshooting, and lifecycle support. · Excellent ...
New
Automation and Controls Engineer
Silver Spring, MD · On-site
$92K - $117K/yr
Execute Computer System Validation (CSV) activities per 21 CFR Part 11 and EU Annex 11, including authoring and executing IQ/OQ/PQ protocols, managing change control records, and maintaining audit ...
Quick apply
Automation and Controls Engineer
Silver Spring, MD · On-site
$92K - $117K/yr
Execute Computer System Validation (CSV) activities per 21 CFR Part 11 and EU Annex 11, including authoring and executing IQ/OQ/PQ protocols, managing change control records, and maintaining audit ...
Automation and Controls Engineer
Silver Spring, MD · On-site
$92K - $117K/yr
Execute Computer System Validation (CSV) activities per 21 CFR Part 11 and EU Annex 11, including authoring and executing IQ/OQ/PQ protocols, managing change control records, and maintaining audit ...
Automation and Controls Engineer
Silver Spring, MD · On-site
$92K - $117K/yr
Execute Computer System Validation (CSV) activities per 21 CFR Part 11 and EU Annex 11, including authoring and executing IQ/OQ/PQ protocols, managing change control records, and maintaining audit ...
Strong background in Computer System Validation (CSV). * Hands-on experience executing IQ/OQ/PQ protocols. * Proven experience developing Validation Master Plans (VMPs), validation protocols, and ...
Strong background in Computer System Validation (CSV). * Hands-on experience executing IQ/OQ/PQ protocols. * Proven experience developing Validation Master Plans (VMPs), validation protocols, and ...
Freelance Computer System Validation Csv information
- Computer System Validation Csv Remote
- Director Computer System Validation Csv
- Verification And Validation
- Commissioning Qualification Validation Cqv
- Csv Validation Consultant
- Engineer Syncade Or Pharmasuite Mes System
- Verification Validation Engineer
- Senior Computer System Validation Csv
- Freelance Work From Home Computer System Validation Csv
- Computer Validation
Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Re-posted 6 days ago
Job description
Quality Agents, LLC offers validation and quality expertise to the pharmaceutical and biotechnology industries.
Our Computer Systems Validation Leads work directly with our clients to support activities that include, but are not limited to, documentation review and approval, including change controls, assessment plans, risk assessment reports, compliance plans, user requirements, system and user acceptance testing protocols, traceability matrix, error reports/defect report forms and summary reports. The individual will contribute directly to the completion of projects through the management of assigned contract personnel, development and execution of validation change control documents, and development and review of protocols, reports and data tables generated by peers and contract personnel. Responsibilities include:
- Optimization of CQV support process, including developing including developing standards and KPI reports.
- Compile and analyze validation data and make recommendations for changes and/or improvements
- Maintain all documentation pertaining to computer systems validation
- Data integrity qualification
- Participate in cross-functional project teams including development & deployment teams as well as customer Manufacturing, Engineering, Quality and other groups
- Some travel is required
Skill level & requirements:
- Experience with IQ, OQ, PQ Final reports relating to Computer Systems Validation.
- Experience writing validation master plans.
- Experience with Configuration, design, data and traceability matrices.
- Validation experience with automated systems is preferred
- Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11
- Strong knowledge of computerized system development life cycle approach is required
- Strong leadership skills and the ability to work in cross-functional team environments, as well as independently
- Experience coordinating Quality documentation, specifically qualification/Validation documentation
- Demonstrated excellent leadership/Project Manager skills
- Strong technical writing skills
- Excellent written and verbal communication skills
- The ability to work and make decisions independently and have the flexibility to adapt to changing priorities is required
Minimum Requirements:
- Bachelor's degree in a technical discipline (i.e. Engineering, Chemistry, Microbiology, Biology)
- 3 - 5 years Computer Systems Validation background
- 3 - 5 years IT Quality Assurance / Validation experience
- Current driver's license and auto insurance or other means of independent transportation
Quality Agents offers a full suite of benefits for full-time employees including:
- Health, dental and vision insurance
- Life, AD&D and Disability Insurance
- Health savings account for participants in our health plan
- 401k retirement plan
- Paid time off
- Paid holidays
Quality Agents accepts applications on an on-going basis in order to build a talent pool of potential candidates. These applications remain open for consideration, as positions become available, for one (1) year from the date of application.After that time, or if your application information changes, please submit your application again.
About Quality Agents
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
11 - 50 Employees
Headquarters location
Wilmington, NC, US
Year founded
2010