Katalyst CRO is seeking a Computer System Validation (CSV) Engineer for a global pharmaceutical client. This role will lead and execute validation activities for GxP electronic systems and ...
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76 Cai System Validation Engineer Jobs Hiring Near You
Katalyst CRO is seeking a Computer System Validation (CSV) Engineer for a global pharmaceutical client. This role will lead and execute validation activities for GxP electronic systems and ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Computer Systems Validation (CSV) experience writing validation deliverables per GAMP guidelines is required. * Understanding of programming and relational database concepts is required. Required ...
Computer Systems Validation (CSV) experience writing validation deliverables per GAMP guidelines is required. * Understanding of programming and relational database concepts is required. Required ...
* 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 ...
* 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 ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
New
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
New
We are seeking an experienced Computer System Validation (CSV) Engineer/Contractor to lead and execute validation activities for GxP computerized systems, with a strong focus on Manufacturing ...
We are seeking an experienced Computer System Validation (CSV) Engineer/Contractor to lead and execute validation activities for GxP computerized systems, with a strong focus on Manufacturing ...
We are seeking an experienced Computer System Validation (CSV) Engineer/Contractor to lead and execute validation activities for GxP computerized systems, with a strong focus on Manufacturing ...
We are seeking an experienced Computer System Validation (CSV) Engineer/Contractor to lead and execute validation activities for GxP computerized systems, with a strong focus on Manufacturing ...
Ensure system validation aligns with Data Integrity principles (ALCOA) and includes appropriate ... Bachelor's degree in Computer Science, Engineering, Biological Sciences, or a related field.
Ensure system validation aligns with Data Integrity principles (ALCOA) and includes appropriate ... Bachelor's degree in Computer Science, Engineering, Biological Sciences, or a related field.
Katalyst CRO is seeking a Computer System Validation (CSV) Engineer for a global pharmaceutical client. This role involves leading and executing validation activities for GxP electronic systems and ...
Katalyst CRO is seeking a Computer System Validation (CSV) Engineer for a global pharmaceutical client. This role involves leading and executing validation activities for GxP electronic systems and ...
We have an opportunity for a forward-thinking and especially hardworking system validation engineer with strong background in high speed serial links. As a member of our dynamic team, you will have ...
We have an opportunity for a forward-thinking and especially hardworking system validation engineer with strong background in high speed serial links. As a member of our dynamic team, you will have ...
Ensure system validation aligns with Data Integrity principles (ALCOA) and includes appropriate ... Bachelor's degree in computer science, Engineering, Biological Sciences, or a related field.
Ensure system validation aligns with Data Integrity principles (ALCOA) and includes appropriate ... Bachelor's degree in computer science, Engineering, Biological Sciences, or a related field.
Ensure system validation aligns with Data Integrity principles (ALCOA) and includes appropriate ... Bachelor's degree in Computer Science, Engineering, Biological Sciences, or a related field.
Ensure system validation aligns with Data Integrity principles (ALCOA) and includes appropriate ... Bachelor's degree in Computer Science, Engineering, Biological Sciences, or a related field.
Ensure system validation aligns with Data Integrity principles (ALCOA) and includes appropriate ... Bachelor's degree in computer science, Engineering, Biological Sciences, or a related field.
Ensure system validation aligns with Data Integrity principles (ALCOA) and includes appropriate ... Bachelor's degree in computer science, Engineering, Biological Sciences, or a related field.
Computer System Validation Engineer
$82K - $104K/yr
The Computer System Validation Engineer is responsible for providing technical validation support for manufacturing equipment, laboratory instruments, computer systems, networks, and software that ...
Computer System Validation Engineer
$82K - $104K/yr
The Computer System Validation Engineer is responsible for providing technical validation support for manufacturing equipment, laboratory instruments, computer systems, networks, and software that ...
Ensure system validation aligns with Data Integrity principles (ALCOA) and includes appropriate ... Bachelor's degree in computer science, Engineering, Biological Sciences, or a related field.
Ensure system validation aligns with Data Integrity principles (ALCOA) and includes appropriate ... Bachelor's degree in computer science, Engineering, Biological Sciences, or a related field.
We have an opportunity for a forward-thinking and especially hardworking system validation engineer with strong background in high speed serial links. As a member of our dynamic team, you will have ...
We have an opportunity for a forward-thinking and especially hardworking system validation engineer with strong background in high speed serial links. As a member of our dynamic team, you will have ...
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Job description
Job Summary:
Katalyst CRO is seeking a Computer System Validation (CSV) Engineer for a global pharmaceutical client. This role will lead and execute validation activities for GxP electronic systems and applications, ensuring compliance with regulatory requirements and supporting Manufacturing Execution Systems (MES). The CSV Engineer will collaborate with various teams to create and manage validation deliverables throughout the validation lifecycle.
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 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.
Qualifications:
Required:
• 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.
Company:
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide. Founded in , the company is headquartered in South Plainfield, USA, with a team of 51-200 employees. The company is currently Growth Stage.
Katalyst CRO is seeking a Computer System Validation (CSV) Engineer for a global pharmaceutical client. This role will lead and execute validation activities for GxP electronic systems and applications, ensuring compliance with regulatory requirements and supporting Manufacturing Execution Systems (MES). The CSV Engineer will collaborate with various teams to create and manage validation deliverables throughout the validation lifecycle.
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 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.
Qualifications:
Required:
• 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.
Company:
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide. Founded in , the company is headquartered in South Plainfield, USA, with a team of 51-200 employees. The company is currently Growth Stage.