Understanding of computer system validation. * Familiarity with MES systems (i.e. Emerson Syncade), ERP systems (i.e. SAP or Oracle) and EBRs (i.e. InfoBatch). * Understanding of computer system ...
Understanding of computer system validation. * Familiarity with MES systems (i.e. Emerson Syncade), ERP systems (i.e. SAP or Oracle) and EBRs (i.e. InfoBatch). * Understanding of computer system ...
Strong knowledge of computerized system development life cycle approach is required * Strong ... year from the date of application. After that time, or if your application information changes ...
Strong knowledge of computerized system development life cycle approach is required * Strong ... year from the date of application. After that time, or if your application information changes ...
Strong knowledge of computerized system development life cycle approach is required * Strong ... year from the date of application.After that time, or if your application information changes ...
Strong knowledge of computerized system development life cycle approach is required * Strong ... year from the date of application.After that time, or if your application information changes ...
Strong knowledge of computerized system development life cycle approach is required * Strong ... year from the date of application.After that time, or if your application information changes ...
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Strong knowledge of computerized system development life cycle approach is required * Strong ... year from the date of application.After that time, or if your application information changes ...
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 ...
Quick apply
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 ...
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
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
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 System Analyst
Arlington, VA · On-site
$39 - $43/hr
One Federal Solution is seeking a Computer Systems Analyst to support the United States Marshals Service (USMS) by providing systems analysis, application development, reporting, and technical ...
Computer System Analyst
Arlington, VA · On-site
$39 - $43/hr
One Federal Solution is seeking a Computer Systems Analyst to support the United States Marshals Service (USMS) by providing systems analysis, application development, reporting, and technical ...
Computer System Analyst
Arlington, VA · On-site
$39 - $43/hr
One Federal Solution is seeking a Computer Systems Analyst to support the United States Marshals Service (USMS) by providing systems analysis, application development, reporting, and technical ...
Computer System Analyst
Arlington, VA · On-site
$39 - $43/hr
One Federal Solution is seeking a Computer Systems Analyst to support the United States Marshals Service (USMS) by providing systems analysis, application development, reporting, and technical ...
Computer System Analyst
Arlington, VA · On-site
$39 - $43/hr
One Federal Solution is seeking a Computer Systems Analyst to support the United States Marshals Service (USMS) by providing systems analysis, application development, reporting, and technical ...
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Computer System Analyst
Arlington, VA · On-site
$39 - $43/hr
One Federal Solution is seeking a Computer Systems Analyst to support the United States Marshals Service (USMS) by providing systems analysis, application development, reporting, and technical ...
Bachelor's degree from an accredited college or university with a major in computer science, information systems, engineering, business, or a related scientific or technical discipline. (Note: A ...
Bachelor's degree from an accredited college or university with a major in computer science, information systems, engineering, business, or a related scientific or technical discipline. (Note: A ...
... from healthcare data, supporting critical decision-making within the military and defense health ... systems. * Bachelor's degree in Business, Data Science, Computer Science or a related field.
... from healthcare data, supporting critical decision-making within the military and defense health ... systems. * Bachelor's degree in Business, Data Science, Computer Science or a related field.
Network Computer System Administrator
Mclean, VA · On-site
$70K - $95K/yr
Overview The Network Computer System Admin supports the United States (U.S.) Army C5ISR Center to ... Produce computing solutions derived from DoW security policies and regulations to ensure that the ...
Network Computer System Administrator
Mclean, VA · On-site
$70K - $95K/yr
Overview The Network Computer System Admin supports the United States (U.S.) Army C5ISR Center to ... Produce computing solutions derived from DoW security policies and regulations to ensure that the ...
Network Computer System Administrator
$70K - $95K/yr
The Network Computer System Admin supports the United States (U.S.) Army C5ISR Center to develop ... Produce computing solutions derived from DoW security policies and regulations to ensure that the ...
Network Computer System Administrator
$70K - $95K/yr
The Network Computer System Admin supports the United States (U.S.) Army C5ISR Center to develop ... Produce computing solutions derived from DoW security policies and regulations to ensure that the ...
Computer Systems Specialist
$29 - $32/hr
... system delivery specifications and owner security requirements ... Supporting roles include basic configuration or programming of anything from a stand alone video ...
Computer Systems Specialist
$29 - $32/hr
... system delivery specifications and owner security requirements ... Supporting roles include basic configuration or programming of anything from a stand alone video ...
Jr. Validation Engineer/QA Analyst/ Jr. QA Tester
Herndon, VA · On-site
$55K - $58K/yr
... clients from a broad range of Industries. ITE is an end-to-end global consulting & solutions ... and Computer System Validation. Description : WE ARE LOOKING FOR FRESH GRADUATES FOR QA and ...
Jr. Validation Engineer/QA Analyst/ Jr. QA Tester
Herndon, VA · On-site
$55K - $58K/yr
... clients from a broad range of Industries. ITE is an end-to-end global consulting & solutions ... and Computer System Validation. Description : WE ARE LOOKING FOR FRESH GRADUATES FOR QA and ...
... clients from a broad range of Industries. ITE is an end-to-end global consulting & solutions ... and Computer System Validation. Description : WE ARE LOOKING FOR FRESH GRADUATES FOR QA and ...
... clients from a broad range of Industries. ITE is an end-to-end global consulting & solutions ... and Computer System Validation. Description : WE ARE LOOKING FOR FRESH GRADUATES FOR QA and ...
Computer Security Systems Specialist (ITS14) Custom Computer Programming Services
Silver Spring, MD · On-site
... and validation; system design; code generation; testing; deployment; and documentation. The ... from any other source. * Task 5: Data Migration and Management Support: The Contractor shall ...
Computer Security Systems Specialist (ITS14) Custom Computer Programming Services
Silver Spring, MD · On-site
... and validation; system design; code generation; testing; deployment; and documentation. The ... from any other source. * Task 5: Data Migration and Management Support: The Contractor shall ...
WORK FROM HOME - Customer Service Representative - 40 hrs per week
Reston, VA · On-site +1
$30K - $60K/yr
Using your home computer and phone to answer inbound phone calls, video calls, and/or live chats to ... Access to smart phone for system verification required Technical Requirements (Read Carefully)
WORK FROM HOME - Customer Service Representative - 40 hrs per week
Reston, VA · On-site +1
$30K - $60K/yr
Using your home computer and phone to answer inbound phone calls, video calls, and/or live chats to ... Access to smart phone for system verification required Technical Requirements (Read Carefully)
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 ... from design, development to implementation of IT solutions. * Familiarity with cell therapy ...
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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 ... from design, development to implementation of IT solutions. * Familiarity with cell therapy ...
From Home Computer System Validation information
What is the difference between From Home Computer System Validation vs From Home Quality Assurance Specialist?
| Aspect | From Home Computer System Validation | From Home Quality Assurance Specialist |
|---|---|---|
| Certifications | GxP validation, 21 CFR Part 11 | ISO 9001, QA certifications |
| Work Environment | Primarily remote, focused on system testing and validation | Remote or onsite, focused on process audits and compliance |
| Industry Usage | Pharmaceutical, biotech, healthcare | Manufacturing, software, healthcare |
| Job Focus | Ensuring computer systems meet regulatory standards | Ensuring overall quality processes and compliance |
From Home Computer System Validation primarily involves verifying that computer systems meet regulatory standards, especially in healthcare and biotech industries. In contrast, From Home Quality Assurance Specialist focuses on broader quality processes and compliance across various industries. Both roles may be remote and require similar certifications, but their core responsibilities differ in scope and focus.

Job description
PURPOSE AND SCOPE OF POSITION:
The Computer Systems Validation (CSV) Contractor works cross-functionally to lead and execute validation activities for GxP electronic systems and applications. This role is an individual contributor. The CSV Contractor will partner with Business Owners, Technical Owners, and Quality to create and manage validation deliverables for electronic systems and applications throughout the validation lifecycle. The CSV Contractor has primary responsibility to ensure that the tasks supporting validation of Manufacturing Execution Systems (MES) are documented in accordance with the relevant client procedures and regulations.
DUTIES AND RESPONSIBILITIES:
- Author, review and/or approve applicable CSV documentation
- Assist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal procedures
- Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations
- Other related duties as assigned
Skills
MES experience Required
unicorn
Syncade.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- Ability to effectively communicate with both technical and non-technical team members.
- Strong interpersonal skills, especially regarding team work, client focus, verbal and written communication
- Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.
- Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing.
- Knowledge of IT service management platforms to support incident, problem and change IT operational events (i.e. ServiceNow).
- Knowledge and exposure to Business Quality Management Systems (i.e. Veeva).
- Strong technical and problem-solving skills and the ability to work independently.
- Demonstrated success working in a high-performing, business results-driven environment.
- Understanding of computer system validation.
- Familiarity with MES systems (i.e. Emerson Syncade), ERP systems (i.e. SAP or Oracle) and EBRs (i.e. InfoBatch).
- Understanding of computer system validation (CSV).
Education and Experience:
- Bachelor's degree in a life sciences or engineering / IT discipline or equivalent industry experience (a combination of industry-specific education and work experience may be used to substitute this degree requirement) 4+ years of direct experience with CSV activities, strong knowledge of GAMP / risk-based approaches to validation and good understanding of electronic records and signatures
- Strong knowledge on Manufacturing Execution System (MES) validation.
- Strong knowledge of regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records / signatures
- Strong knowledge on development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.)
About Orion Innovation
Sourced by ZipRecruiter
Industry
It services
Company size
1,001 - 5,000 Employees
Headquarters location
Edison, NJ, US
Year founded
1993