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 ...

73 Meta System Validation Engineer Jobs Hiring Near You
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 ...
Role Overview As an Entry-Level System Validation Engineer on the Taurus team, you will validate Astera Labs' Taurus Ethernet Smart Cable Modules and Taurus ASICs . You'll work on chip bring-up ...
Role Overview As an Entry-Level System Validation Engineer on the Taurus team, you will validate Astera Labs' Taurus Ethernet Smart Cable Modules and Taurus ASICs . You'll work on chip bring-up ...
Job Summary We are seeking a Senior System Validation Engineer to design and implement validation tests for Arm-based data center SoCs using a combination of open-source benchmarking tools and custom ...
Job Summary We are seeking a Senior System Validation Engineer to design and implement validation tests for Arm-based data center SoCs using a combination of open-source benchmarking tools and custom ...
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 ...
Sensor System Validation Engineer
$60 - $65/hr
Sensor System Validation Engineer * Location: 100% Onsite in Foster City, CA | 5 days in office * Duration : 6 month assignment - Contract extension potential * Pay: Negotiable depending on direct ...
Sensor System Validation Engineer
$60 - $65/hr
Sensor System Validation Engineer * Location: 100% Onsite in Foster City, CA | 5 days in office * Duration : 6 month assignment - Contract extension potential * Pay: Negotiable depending on direct ...
Embedded System Validation Engineer Job Location: Redmond, WA (Onsite) Job Type: Full Time Key Responsibilities: * Convert product and firmware requirements into structured test plans, validation ...
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Embedded System Validation Engineer Job Location: Redmond, WA (Onsite) Job Type: Full Time Key Responsibilities: * Convert product and firmware requirements into structured test plans, validation ...
Support IO Check, system integration, and validation for startup activities. * Provide technical assistance to OEM engineers and facilitate system integration. * Participate in SAT/IQ/OQ phases ...
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Support IO Check, system integration, and validation for startup activities. * Provide technical assistance to OEM engineers and facilitate system integration. * Participate in SAT/IQ/OQ phases ...
Computer Systems Validation Engineer
$80K - $100K/yr
Join us as a Computer Systems Validation Engineer! Join Abeona Therapeutics Inc. as a Computer ... Strong expertise in end-to-end GxP computer system validation (CSV), with a thorough understanding ...
Computer Systems Validation Engineer
$80K - $100K/yr
Join us as a Computer Systems Validation Engineer! Join Abeona Therapeutics Inc. as a Computer ... Strong expertise in end-to-end GxP computer system validation (CSV), with a thorough understanding ...
Job Summary We are seeking a Senior System Validation Engineer to design and implement validation tests for Arm-based data center SoCs using a combination of open-source benchmarking tools and custom ...
Job Summary We are seeking a Senior System Validation Engineer to design and implement validation tests for Arm-based data center SoCs using a combination of open-source benchmarking tools and custom ...
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 ...
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 ...
Computer Systems Validation Engineer
Cleveland, OH · On-site
$80K - $100K/yr
Join us as a Computer Systems Validation Engineer! Join Abeona Therapeutics Inc. as a Computer ... Strong expertise in end-to-end GxP computer system validation (CSV), with a thorough understanding ...
Quick apply
Computer Systems Validation Engineer
Cleveland, OH · On-site
$80K - $100K/yr
Join us as a Computer Systems Validation Engineer! Join Abeona Therapeutics Inc. as a Computer ... Strong expertise in end-to-end GxP computer system validation (CSV), with a thorough understanding ...
Support IO Check, system integration, and validation for startup activities. * Provide technical assistance to OEM engineers and facilitate system integration. * Participate in SAT/IQ/OQ phases ...
Quick apply
Support IO Check, system integration, and validation for startup activities. * Provide technical assistance to OEM engineers and facilitate system integration. * Participate in SAT/IQ/OQ phases ...
Senior System Validation Engineer
San Jose, CA · Hybrid
$122K - $167K/yr
Senior System Validation Engineer This exciting role will be responsible for validating high-speed memory buffer semiconductor products, developing automation scripts, and ensuring system compliance ...
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Senior System Validation Engineer
San Jose, CA · Hybrid
$122K - $167K/yr
Senior System Validation Engineer This exciting role will be responsible for validating high-speed memory buffer semiconductor products, developing automation scripts, and ensuring system compliance ...
Computer System Validation Engineer
Tustin, CA · On-site
$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
Tustin, CA · On-site
$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 ...
Senior System Validation Engineer
Johns Creek, GA · Hybrid
$96K - $132K/yr
Senior System Validation Engineer This exciting role will be responsible for validating high-speed memory buffer semiconductor products, developing automation scripts, and ensuring system compliance ...
Quick apply
Senior System Validation Engineer
Johns Creek, GA · Hybrid
$96K - $132K/yr
Senior System Validation Engineer This exciting role will be responsible for validating high-speed memory buffer semiconductor products, developing automation scripts, and ensuring system compliance ...
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 ...
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 ...
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 ...
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 ...
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 ...
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Other
Posted 16 days ago
Key responsibilities
Author, review, and approve applicable Computer System Validation documentation.
Assist Business Owners and Technical Owners during test execution, document test failures, and ensure testing aligns with internal procedures.
Develop and maintain CSV documentation including Validation Plans, Requirements, Specifications, Assessments, Test Scripts, Summary Reports, Trace Matrices, and SOPs.
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
Sourced by ZipRecruiter
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