Bachelor's degree in Life Sciences, Engineering, IT, or a related discipline, or equivalent industry experience. * Minimum 4+ years of direct experience in Computer System Validation (CSV). * Strong ...
Validation Engineering Group
60 Validation Engineering Group System Validation Engineer Jobs Hiring Near You
Bachelor's degree in Life Sciences, Engineering, IT, or a related discipline, or equivalent industry experience. * Minimum 4+ years of direct experience in Computer System Validation (CSV). * Strong ...
You will closely work with a talented group of Analog-Mixed/Signal designers working diligently to ... We have an opportunity for a forward-thinking and especially hardworking system validation engineer ...
You will closely work with a talented group of Analog-Mixed/Signal designers working diligently to ... We have an opportunity for a forward-thinking and especially hardworking system validation engineer ...
Validation Engineer III
Boston, MA · On-site
BW Design Group is a fully integrated architecture, engineering, construction, system integration ... Job Summary The Validation Engineer III will serve as a key member of the validation team ...
Validation Engineer III
Boston, MA · On-site
BW Design Group is a fully integrated architecture, engineering, construction, system integration ... Job Summary The Validation Engineer III will serve as a key member of the validation team ...
You will closely work with a talented group of Analog-Mixed/Signal designers working diligently to ... We have an opportunity for a forward-thinking and especially hardworking system validation engineer ...
You will closely work with a talented group of Analog-Mixed/Signal designers working diligently to ... We have an opportunity for a forward-thinking and especially hardworking system validation engineer ...
Develop and execute system-level V&V test plans for fully integrated humanoid robots, working with Systems Engineering to translate requirements into testable validation criteria with clear pass/fail ...
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Develop and execute system-level V&V test plans for fully integrated humanoid robots, working with Systems Engineering to translate requirements into testable validation criteria with clear pass/fail ...
Validation Engineer
Buffalo Grove, IL · On-site
$55 - $65/hr
... systems. Perform risk assessments utilizing FMEA and other risk management tools. Investigate ... Collaborate with Manufacturing Engineering to optimize molding parameters, cycle times, and process ...
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Validation Engineer
Buffalo Grove, IL · On-site
$55 - $65/hr
... systems. Perform risk assessments utilizing FMEA and other risk management tools. Investigate ... Collaborate with Manufacturing Engineering to optimize molding parameters, cycle times, and process ...
Validation Engineer (CSV)
Redmond, WA · On-site
... Automation, Engineering, Manufacturing, Quality, and IT teams to ensure compliant system ... Validation Plans * Risk Assessments * Requirements Traceability Matrices (RTMs) * Installation ...
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Validation Engineer (CSV)
Redmond, WA · On-site
... Automation, Engineering, Manufacturing, Quality, and IT teams to ensure compliant system ... Validation Plans * Risk Assessments * Requirements Traceability Matrices (RTMs) * Installation ...
This role will involve qualifying and maintaining equipment and systems in compliance with ... Bachelor's degree in Engineering, Computer Science, or equivalent (or Associate's degree with 4+ ...
This role will involve qualifying and maintaining equipment and systems in compliance with ... Bachelor's degree in Engineering, Computer Science, or equivalent (or Associate's degree with 4+ ...
Engineering Site Lead
$98K - $130K/yr
Validation & Engineering Group, Inc. a Pinnaql company is a leading services supplier who provides ... Familiarity with automation systems * Experience in fast-paced or short-term project environments ...
Engineering Site Lead
$98K - $130K/yr
Validation & Engineering Group, Inc. a Pinnaql company is a leading services supplier who provides ... Familiarity with automation systems * Experience in fast-paced or short-term project environments ...
Validation Engineer
Waltham, MA · On-site
Support validation of sterilization and cleaning systems, including CIP Skids, isolators, parts ... Collaborate with manufacturing, quality, and engineering teams to troubleshoot issues and resolve ...
Validation Engineer
Waltham, MA · On-site
Support validation of sterilization and cleaning systems, including CIP Skids, isolators, parts ... Collaborate with manufacturing, quality, and engineering teams to troubleshoot issues and resolve ...
Validation Engineer
Waltham, MA · On-site
Support validation of sterilization and cleaning systems, including CIP Skids, isolators, parts ... Collaborate with manufacturing, quality, and engineering teams to troubleshoot issues and resolve ...
Validation Engineer
Waltham, MA · On-site
Support validation of sterilization and cleaning systems, including CIP Skids, isolators, parts ... Collaborate with manufacturing, quality, and engineering teams to troubleshoot issues and resolve ...
Validation Engineer III
Boston, MA · On-site
BW Design Group is a fully integrated architecture, engineering, construction, system integration ... Job Summary The Validation Engineer III will serve as a key member of the validation team ...
Validation Engineer III
Boston, MA · On-site
BW Design Group is a fully integrated architecture, engineering, construction, system integration ... Job Summary The Validation Engineer III will serve as a key member of the validation team ...
Field Validation Engineer
Cleveland, OH · On-site
... system performance, and compliance requirements * Support customer escalations and validation-related technical inquiries * Collaborate with internal teams including Engineering, Technical Support ...
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Field Validation Engineer
Cleveland, OH · On-site
... system performance, and compliance requirements * Support customer escalations and validation-related technical inquiries * Collaborate with internal teams including Engineering, Technical Support ...
Validation Engineer
Austin, TX · Hybrid
... of the Systems Engineering department supporting hardware validation and debugging efforts. The ideal candidate will demonstrate strong technical expertise, problem-solving skills, and a ...
Validation Engineer
Austin, TX · Hybrid
... of the Systems Engineering department supporting hardware validation and debugging efforts. The ideal candidate will demonstrate strong technical expertise, problem-solving skills, and a ...
Senior System Validation Engineer
Johns Creek, GA · Hybrid
$96K - $132K/yr
S. in Computer Engineering, Electrical Engineering, or related field. * 5+ years of experience in system validation, memory interfaces, or related semiconductor work. * Must have expertise in high ...
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Senior System Validation Engineer
Johns Creek, GA · Hybrid
$96K - $132K/yr
S. in Computer Engineering, Electrical Engineering, or related field. * 5+ years of experience in system validation, memory interfaces, or related semiconductor work. * Must have expertise in high ...
... validation, computer systems validation, and inspection/packaging validation activities. The ... Bachelor's degree in Engineering, Chemistry, Biochemistry, Microbiology, Pharmacy or related ...
... validation, computer systems validation, and inspection/packaging validation activities. The ... Bachelor's degree in Engineering, Chemistry, Biochemistry, Microbiology, Pharmacy or related ...
Systems Validation Engineer
Goleta, CA · On-site
$57 - $62/hr
Systems Validation Engineer Location: Goleta, CA Onsite Flexibility: Onsite Contract Details ... in engineering verification or validation is required Benefits * Medical, Vision, and Dental ...
Systems Validation Engineer
Goleta, CA · On-site
$57 - $62/hr
Systems Validation Engineer Location: Goleta, CA Onsite Flexibility: Onsite Contract Details ... in engineering verification or validation is required Benefits * Medical, Vision, and Dental ...
Influence cross-functional engineering initiatives and contribute to defining departmental best ... Hands-on experience with SDLC (System Development Life Cycle) . * Excellent organizational, verbal ...
Influence cross-functional engineering initiatives and contribute to defining departmental best ... Hands-on experience with SDLC (System Development Life Cycle) . * Excellent organizational, verbal ...
PR · On-site
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Support investigations, CAPA activities, and quality system documentation associated with project ...
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PR · On-site
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Support investigations, CAPA activities, and quality system documentation associated with project ...
Validation Engineer
Cambridge, MA · On-site
... System Validation (CSV) in accordance with GAMP 5. * solid working knowledge of regulatory ... Cross-functional collaboration with Quality, Manufacturing Engineering, R&D, QC, Regulatory Affairs ...
Validation Engineer
Cambridge, MA · On-site
... System Validation (CSV) in accordance with GAMP 5. * solid working knowledge of regulatory ... Cross-functional collaboration with Quality, Manufacturing Engineering, R&D, QC, Regulatory Affairs ...
Validation Engineering Group Jobs Information
What other companies are hiring for System Validation Engineer jobs?
Full-time
Re-posted 9 days ago
Job description
Job Description:
- We are seeking a Computer System Validation (CSV) Engineer for a global pharmaceutical client. This role will work cross-functionally to lead and execute validation activities for GxP electronic systems and applications.
- The CSV Engineer will partner with Business Owners, Technical Owners, and Quality teams to create and manage validation deliverables throughout the validation lifecycle.
- The primary responsibility is to ensure that validation activities supporting Manufacturing Execution Systems (MES) are documented in accordance with applicable procedures and regulatory requirements.
- 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 in developing requirements and specifications for computerized systems used in GxP operations.
- Support validation activities for Manufacturing Execution Systems (MES).
- Develop and maintain CSV documentation including Validation Plans, Requirements, Specifications, Assessments, Test Scripts (IQ/OQ/PQ or equivalent), Summary Reports, Trace Matrices, and SOPs.
- Ensure compliance with cGMP, GxP, GAMP, SDLC regulations, 21 CFR Part 11, and Good Documentation Practices.
- Support validation of pharmaceutical manufacturing and laboratory systems used in biologics and clinical manufacturing environments.
- Utilize IT service management platforms to support incident, problem, and change management activities.
- Work with Business Quality Management Systems and related validation processes.
- Bachelor's degree in Life Sciences, Engineering, IT, or a related discipline, or equivalent industry experience.
- Minimum 4+ years of direct experience in Computer System Validation (CSV).
- Strong knowledge of GAMP and risk-based validation approaches.
- Good understanding of electronic records and electronic signatures.
- Strong knowledge of Manufacturing Execution System (MES) validation.
- Familiarity with MES systems such as Emerson Syncade, ERP systems such as SAP or Oracle, and EBR systems such as InfoBatch.
- Strong experience developing CSV documentation, including Validation Plans, Requirements, Specifications, Assessments, Test Scripts, Summary Reports, Trace Matrices, and SOPs.
- Knowledge of pharmaceutical, manufacturing, and laboratory systems supporting biologics and clinical manufacturing.
- Experience with IT service management platforms such as ServiceNow.
- Exposure to Business Quality Management Systems such as Veeva.
About Katalyst Healthcares & Life Sciences
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Katalyst HealthCares & Life Sciences is a Global Contract Research Organization that provides services in Clinical Research, Manufacturing & Quaity, Regulatory Affairs Areas.. Industries Serving: Pharmaceutical Bio-Pharmaceutical Medical Device Cosmeceuticals & Cosmetics Food & Beverage Clinical Research Scientific Areas Covering: Clinical Research Manufacturing Quality & Validations Regulatory Affairs Intellectual Property Through our in-house team expertise, associates and alliances in the US, Europe and Asia, we can rapidly deliver services, technology, processes and workforce globally, either virtually or integrate into client project space, providing oversight and expertise for individual needs to total end-to-end support for all kinds of clinical trials of Pharma, Biotech, Medical Device and all other scientific products and their manufacturing.
Industry
Scientific research and development services
Company size
51 - 200 Employees
Headquarters location
South Plainfield, NJ, US