CSV Engineer
Columbus, OH · On-site
... analytical lab instruments, and the Metasys Client. * By maintaining data integrity and system compliance, the CSV Engineer plays a critical part in ensuring product quality, patient safety, and ...
72 Katalyst Data Analyst Jobs Hiring Near You
CSV Engineer
Columbus, OH · On-site
... analytical lab instruments, and the Metasys Client. * By maintaining data integrity and system compliance, the CSV Engineer plays a critical part in ensuring product quality, patient safety, and ...
Design Engineer L2
Raymond, OH · Hybrid
Reference CAD data of previous program and similar programs. * Class A surface. * Guidance sections ... Must be able to proficiently handle multiple projects and develop analytical procedures. * Must be ...
Design Engineer L2
Raymond, OH · Hybrid
Reference CAD data of previous program and similar programs. * Class A surface. * Guidance sections ... Must be able to proficiently handle multiple projects and develop analytical procedures. * Must be ...
Build knowledge how to Analyze & interpret test results, predict performance/failure and provide required product/design data. * Requirements Capture and Specification Development * Write draft ...
Build knowledge how to Analyze & interpret test results, predict performance/failure and provide required product/design data. * Requirements Capture and Specification Development * Write draft ...
Support data migration, interfaces, integrations, and related systems as part of the LIMS implementation * Participate in system change control, deviations, CAPAs, periodic reviews, and other ...
Support data migration, interfaces, integrations, and related systems as part of the LIMS implementation * Participate in system change control, deviations, CAPAs, periodic reviews, and other ...
Quality Manager
Alexandria, OH · On-site
Assess current quality processes, systems, and data flows to identify gaps, inefficiencies, and improvement opportunities. * Define and prioritize essential quality management capabilities based on ...
Quality Manager
Alexandria, OH · On-site
Assess current quality processes, systems, and data flows to identify gaps, inefficiencies, and improvement opportunities. * Define and prioritize essential quality management capabilities based on ...
Analyze supplier performance metrics and recommend improvements. * Assist in negotiating pricing, contracts, and service agreements. * Resolve procurement-related issues including delivery delays and ...
Analyze supplier performance metrics and recommend improvements. * Assist in negotiating pricing, contracts, and service agreements. * Resolve procurement-related issues including delivery delays and ...
Engineer Level 2
Raymond, OH · On-site
Must be able to proficiently handle multiple projects and develop analytical procedures. * Work with suppliers to ensure parts/services are requested appropriately, evaluate technical proposals, and ...
Engineer Level 2
Raymond, OH · On-site
Must be able to proficiently handle multiple projects and develop analytical procedures. * Work with suppliers to ensure parts/services are requested appropriately, evaluate technical proposals, and ...
C&Q Engineer
New Albany, OH · On-site
Maintain accurate and complete C&Q records in compliance with site documentation standards and data integrity requirements Experience: * Experienced Commissioning & Qualification (C&Q) professional ...
C&Q Engineer
New Albany, OH · On-site
Maintain accurate and complete C&Q records in compliance with site documentation standards and data integrity requirements Experience: * Experienced Commissioning & Qualification (C&Q) professional ...
Analyze designs and systems for compliance to applicable standards (i.e. OSHA, CE or customer specific) * Review drawings for accuracy, material selection, proper machining techniques, finishes ...
Analyze designs and systems for compliance to applicable standards (i.e. OSHA, CE or customer specific) * Review drawings for accuracy, material selection, proper machining techniques, finishes ...
Job Summary : We are seeking an experienced Senior Validation Engineer / Senior CQV Engineer to support commissioning, qualification, and validation activities for equipment, systems, software, and ...
Job Summary : We are seeking an experienced Senior Validation Engineer / Senior CQV Engineer to support commissioning, qualification, and validation activities for equipment, systems, software, and ...
GIS Specialist
Columbus, OH · On-site
Required Qualifications : * Bachelor's degree or foreign equivalent required from an accredited institution. Will also consider three years of progressive experience in the specialty in lieu of every ...
GIS Specialist
Columbus, OH · On-site
Required Qualifications : * Bachelor's degree or foreign equivalent required from an accredited institution. Will also consider three years of progressive experience in the specialty in lieu of every ...
Job Summary: We are seeking a highly skilled Sr. Engineer - Process Development (CQV) to support automated and semi-automated combination product assembly, labeling, and packaging operations within a ...
Job Summary: We are seeking a highly skilled Sr. Engineer - Process Development (CQV) to support automated and semi-automated combination product assembly, labeling, and packaging operations within a ...
Senior AI/ML Engineer
Calgary, AB · On-site
Join the dynamic and collaborative team at Katalyst Data Management (KDM)! KDM is seeking a Senior ... Experience with search and analytics platforms such as Elasticsearch/OpenSearch or equivalent.
Quick apply
Senior AI/ML Engineer
Calgary, AB · On-site
Join the dynamic and collaborative team at Katalyst Data Management (KDM)! KDM is seeking a Senior ... Experience with search and analytics platforms such as Elasticsearch/OpenSearch or equivalent.
Senior AI/ML Engineer
Houston, TX · On-site
$99K - $137K/yr
Hybrid Schedule Availability The Company Katalyst Data Management (KDM) is a global leader in ... Experience with search and analytics platforms such as Elasticsearch/OpenSearch or equivalent.
Senior AI/ML Engineer
Houston, TX · On-site
$99K - $137K/yr
Hybrid Schedule Availability The Company Katalyst Data Management (KDM) is a global leader in ... Experience with search and analytics platforms such as Elasticsearch/OpenSearch or equivalent.
Senior AI/ML Engineer
Calgary, AB · On-site
Join the dynamic and collaborative team at Katalyst Data Management (KDM)! KDM is seeking a Senior ... Experience with search and analytics platforms such as Elasticsearch/OpenSearch or equivalent.
Senior AI/ML Engineer
Calgary, AB · On-site
Join the dynamic and collaborative team at Katalyst Data Management (KDM)! KDM is seeking a Senior ... Experience with search and analytics platforms such as Elasticsearch/OpenSearch or equivalent.
Senior AI/ML Engineer
Houston, TX · On-site
$101K - $139K/yr
Join the dynamic and collaborative team at Katalyst Data Management (KDM)! KDM is seeking a Senior ... Experience with search and analytics platforms such as Elasticsearch/OpenSearch or equivalent.
Quick apply
Senior AI/ML Engineer
Houston, TX · On-site
$101K - $139K/yr
Join the dynamic and collaborative team at Katalyst Data Management (KDM)! KDM is seeking a Senior ... Experience with search and analytics platforms such as Elasticsearch/OpenSearch or equivalent.
Katalyst CRO is seeking a Senior Clinical SAS Programmer who will represent the programming ... data displays. Responsibilities : • Developing CDISC-compliant datasets and corresponding ...
Katalyst CRO is seeking a Senior Clinical SAS Programmer who will represent the programming ... data displays. Responsibilities : • Developing CDISC-compliant datasets and corresponding ...
Software Engineer (Retool Platform / Internal Applications)
Warrendale, PA · On-site
$50.50 - $69.50/hr
Job Summary : Katalyst CRO is a company focused on developing internal tools and workflow ... data retrieval processes. Responsibilities : • Design, develop, and maintain internal tools and ...
Software Engineer (Retool Platform / Internal Applications)
Warrendale, PA · On-site
$50.50 - $69.50/hr
Job Summary : Katalyst CRO is a company focused on developing internal tools and workflow ... data retrieval processes. Responsibilities : • Design, develop, and maintain internal tools and ...
Biologist III job at Katalyst Healthcares & Life Sciences. Cambridge, MA. * Impeccable lab ... Ability to analyze, plot, interpret, and present data in team meetings. * Aptitude to communicate ...
Biologist III job at Katalyst Healthcares & Life Sciences. Cambridge, MA. * Impeccable lab ... Ability to analyze, plot, interpret, and present data in team meetings. * Aptitude to communicate ...
Katalyst CRO is a company focused on providing validation and testing services within the Life ... They are seeking a CSV Validation & Testing Lead to ensure system integrity, data accuracy, and ...
Katalyst CRO is a company focused on providing validation and testing services within the Life ... They are seeking a CSV Validation & Testing Lead to ensure system integrity, data accuracy, 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.
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Job description
Job Summary:
- The CSV Engineer is responsible for ensuring that GxP computerized systems at the client site are validated in compliance with regulatory standards (21 CFR Part 11, EU Annex 11, GAMP 5).
- This role directly supports gene therapy manufacturing operations by leading validation activities for key systems, including Veeva QMS, BMRAM, analytical lab instruments, and the Metasys Client.
- By maintaining data integrity and system compliance, the CSV Engineer plays a critical part in ensuring product quality, patient safety, and regulatory inspection readiness.
- Author, review, and execute validation deliverables for GxP computerized systems, including Validation Plans, Requirements Specifications (URS/FS/DS), IQ/OQ/PQ protocols, Trace Matrices, and Validation Summary Reports.
- Support computer system validation efforts for Veeva Vault QMS, BMRAM (laboratory information management), analytical lab instruments (e.g., HPLC, UHPLC, PCR instruments, plate readers etc.), ERP System (NetSuite).
- Perform risk assessments to determine validation approach and ensure appropriate testing of system functionality, data integrity, and audit trail review.
- Manage system change control, deviations, and CAPAs related to validated systems, ensuring compliance with Forge's quality system.
- Collaborate with IT, QA, Lab Operations, and Facilities teams to support system upgrades, patches, and periodic reviews while maintaining a validated state.
- Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field (or equivalent experience).
- 5-7+ years of experience in Computer System Validation (CSV) within a GxP regulated environment (pharmaceutical, biotech, or medical device).
- Working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles (ALCOA+).
- Experience validating at least one of the following: Veeva Vault QMS, BMRAM, laboratory instrumentation (e.g., Waters, Agilent, Chromeleon, Softmax or similar), or a building management system (Client) like Metasys.
- Strong technical writing skills and ability to execute protocols with minimal supervision.
- Nice to have: BMRAM and analytical lab instruments experience.