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 ...
64 Katalyst 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 ...
Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for ... As a Validation Engineer within the Mold & Capital Tooling Organization, you'll play a pivotal role ...
Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for ... As a Validation Engineer within the Mold & Capital Tooling Organization, you'll play a pivotal role ...
CSV Engineer
Somerset, NJ · On-site
Katalyst CRO is seeking an IT CSV Validation Engineer responsible for authoring and executing validation test scripts to support regulated systems within a GxP life sciences environment. This role ...
CSV Engineer
Somerset, NJ · On-site
Katalyst CRO is seeking an IT CSV Validation Engineer responsible for authoring and executing validation test scripts to support regulated systems within a GxP life sciences environment. This role ...
CSV Engineer
Somerset, NJ · On-site
Katalyst CRO is a company focused on providing services in the life sciences sector, and they are seeking an IT CSV Validation Engineer. This role is responsible for authoring and executing ...
CSV Engineer
Somerset, NJ · On-site
Katalyst CRO is a company focused on providing services in the life sciences sector, and they are seeking an IT CSV Validation Engineer. This role is responsible for authoring and executing ...
CSV Engineer
Redwood City, CA · On-site
Katalyst CRO is looking for an experienced and well-rounded CSV (Computer System Validation ... CSV Engineer • Ensuring compliance with validation and regulatory standards Qualifications
CSV Engineer
Redwood City, CA · On-site
Katalyst CRO is looking for an experienced and well-rounded CSV (Computer System Validation ... CSV Engineer • Ensuring compliance with validation and regulatory standards Qualifications
Validation Engineer
Kenosha, WI · On-site
Requirements: * Experienced Validation Engineer with either minimum 3 years experience or Sr. Validation Engineer with minimum 5 years experience performing Validation on aseptic liquid fill ...
Validation Engineer
Kenosha, WI · On-site
Requirements: * Experienced Validation Engineer with either minimum 3 years experience or Sr. Validation Engineer with minimum 5 years experience performing Validation on aseptic liquid fill ...
* Client is looking for onsite Validation Engineers / CQV Engineers to support upcoming qualification work tied to sterile manufacturing and fill/finish operations. The consultants will support hands ...
* Client is looking for onsite Validation Engineers / CQV Engineers to support upcoming qualification work tied to sterile manufacturing and fill/finish operations. The consultants will support hands ...
Validation Engineer
Springfield, MA · On-site
* Client is looking for onsite Validation Engineers / CQV Engineers to support upcoming qualification work tied to sterile manufacturing and fill/finish operations. The consultants will support hands ...
Validation Engineer
Springfield, MA · On-site
* Client is looking for onsite Validation Engineers / CQV Engineers to support upcoming qualification work tied to sterile manufacturing and fill/finish operations. The consultants will support hands ...
Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for ... Creation and review of validation deliverables including but not limited to. Responsibilities:
Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for ... Creation and review of validation deliverables including but not limited to. Responsibilities:
Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for ... Creation and review of validation deliverables including but not limited to Requirement ...
Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for ... Creation and review of validation deliverables including but not limited to Requirement ...
Validation Engineer
Round Lake, IL · On-site
We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products. * The role involves planning and executing V&V ...
Validation Engineer
Round Lake, IL · On-site
We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products. * The role involves planning and executing V&V ...
Validation Engineer
Boston, MA · On-site
We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products. * The role involves planning and executing V&V ...
Validation Engineer
Boston, MA · On-site
We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products. * The role involves planning and executing V&V ...
Katalyst CRO is a company focused on providing validation and testing services within the Life Sciences sector. They are seeking a CSV Validation & Testing Lead to ensure system integrity, data ...
Katalyst CRO is a company focused on providing validation and testing services within the Life Sciences sector. They are seeking a CSV Validation & Testing Lead to ensure system integrity, data ...
Validation Engineer
Irvine, CA · On-site
The Validation Engineer will work under limited supervision to support product validation and engineering activities in a regulated medical device environment. The role focuses on leading Continuous ...
Validation Engineer
Irvine, CA · On-site
The Validation Engineer will work under limited supervision to support product validation and engineering activities in a regulated medical device environment. The role focuses on leading Continuous ...
We are looking for an experienced Validation Engineer with a strong background in the Medical Device industry to support validation and project execution activities. Key Requirements: * bachelor ...
We are looking for an experienced Validation Engineer with a strong background in the Medical Device industry to support validation and project execution activities. Key Requirements: * bachelor ...
We are looking for a Validation Engineer II with experience in the pharmaceutical or biopharmaceutical industry to join our growing team. Roles & Responsibilities: * Develop and execute IQ, OQ, PQ ...
We are looking for a Validation Engineer II with experience in the pharmaceutical or biopharmaceutical industry to join our growing team. Roles & Responsibilities: * Develop and execute IQ, OQ, PQ ...
Validation Engineer
Cambridge, MA · On-site
We are seeking a seasoned Validation Engineer with 10+ years of experience in medical device or regulated manufacturing environments. * Candidates must have strong hands-on expertise in IQ/OQ/PQ ...
Validation Engineer
Cambridge, MA · On-site
We are seeking a seasoned Validation Engineer with 10+ years of experience in medical device or regulated manufacturing environments. * Candidates must have strong hands-on expertise in IQ/OQ/PQ ...
Requirements: * Experienced Validation Engineer with either minimum 3 years experience or Sr. Validation Engineer with minimum 5 years experience performing Validation on aseptic liquid fill ...
Requirements: * Experienced Validation Engineer with either minimum 3 years experience or Sr. Validation Engineer with minimum 5 years experience performing Validation on aseptic liquid fill ...
Validation Engineer
Minneapolis, MN · On-site
We are seeking an experienced Test/Validation Engineer with expertise in manufacturing validation, automated test equipment qualification, and Verification & Validation (V&V) within regulated ...
Validation Engineer
Minneapolis, MN · On-site
We are seeking an experienced Test/Validation Engineer with expertise in manufacturing validation, automated test equipment qualification, and Verification & Validation (V&V) within regulated ...
* We are seeking a proactive Validation Engineer with 1-3 years of experience in a regulated manufacturing environment (medical devices, pharma, or biotech, preferably. FDA) to ensure compliance and ...
* We are seeking a proactive Validation Engineer with 1-3 years of experience in a regulated manufacturing environment (medical devices, pharma, or biotech, preferably. FDA) to ensure compliance and ...
Katalyst Jobs Information
What is it like to work at Katalyst?
Katalyst appears to be a collaborative and innovative company that values creativity and teamwork, fostering an environment where employees can share ideas and work together to achieve common goals.
The company's structure and work environment seem to be designed to support a dynamic and agile approach, with a focus on delivering high-quality results and driving business growth. Katalyst's mission is centered around helping businesses and organizations succeed through strategic partnerships and tailored solutions.
Working at Katalyst may appeal to individuals who are passionate about innovation, collaboration, and making a meaningful impact in their industry, as the company offers opportunities for professional growth, skill development, and contributions to a dynamic and forward-thinking organization.
The company's structure and work environment seem to be designed to support a dynamic and agile approach, with a focus on delivering high-quality results and driving business growth. Katalyst's mission is centered around helping businesses and organizations succeed through strategic partnerships and tailored solutions.
Working at Katalyst may appeal to individuals who are passionate about innovation, collaboration, and making a meaningful impact in their industry, as the company offers opportunities for professional growth, skill development, and contributions to a dynamic and forward-thinking organization.
What makes Katalyst an attractive place to work?
Katalyst is a forward-thinking company that has established itself as a leader in its industry, known for its commitment to innovation and customer satisfaction. The company's work environment is characterized by a collaborative and dynamic atmosphere, where employees are encouraged to share ideas and work together to drive progress. Joining Katalyst offers opportunities for professional growth and development, as well as the chance to contribute to meaningful projects that can have a lasting impact.
What other companies are hiring for Validation Engineer jobs?
What are the most popular jobs at Katalyst?
What are the most popular categories at Katalyst?
Full-time
Re-posted 7 days ago
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.