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 ...
61 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 ...
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 ...
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 ...
The Observational and Real-World Evidence (CORE) Real-World Data Analytics and Innovation (RDAI) team is seeking a Real-World Data (RWD) Technical Analyst to support real-world evidence generation ...
The Observational and Real-World Evidence (CORE) Real-World Data Analytics and Innovation (RDAI) team is seeking a Real-World Data (RWD) Technical Analyst to support real-world evidence generation ...
The Observational and Real-World Evidence (CORE) Real-World Data Analytics and Innovation (RDAI) team is seeking a Real-World Data (RWD) Technical Analyst to support real-world evidence generation ...
The Observational and Real-World Evidence (CORE) Real-World Data Analytics and Innovation (RDAI) team is seeking a Real-World Data (RWD) Technical Analyst to support real-world evidence generation ...
Data Engineer
Toronto, ON · Hybrid
Company Description The Klick Group --comprising Klick Health (including Klick Katalyst and btwelve ... The Data Engineer supports analytics and omnichannel initiatives by designing, building, and ...
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Data Engineer
Toronto, ON · Hybrid
Company Description The Klick Group --comprising Klick Health (including Klick Katalyst and btwelve ... The Data Engineer supports analytics and omnichannel initiatives by designing, building, and ...
Company Description The Klick Group --comprising Klick Health (including Klick Katalyst and btwelve ... The Business Analyst, Omnichannel Enablement supports data-driven healthcare marketing initiatives ...
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Company Description The Klick Group --comprising Klick Health (including Klick Katalyst and btwelve ... The Business Analyst, Omnichannel Enablement supports data-driven healthcare marketing initiatives ...
SAP Process Analyst
Santa Rosa, CA · On-site
This role will focus on process optimization, data analysis, and stakeholder collaboration within a fast-paced, regulated environment. The ideal candidate will have strong SAP expertise, analytical ...
SAP Process Analyst
Santa Rosa, CA · On-site
This role will focus on process optimization, data analysis, and stakeholder collaboration within a fast-paced, regulated environment. The ideal candidate will have strong SAP expertise, analytical ...
Clinical data manager
Omaha, NE · On-site
Utilize statistical software tools for data analysis support and prepare datasets for statistical review and reporting. * Manage documentation workflows, including audit trails, protocol amendments ...
Clinical data manager
Omaha, NE · On-site
Utilize statistical software tools for data analysis support and prepare datasets for statistical review and reporting. * Manage documentation workflows, including audit trails, protocol amendments ...
Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for ... Performs a variety of chemical analyses and GMP review in accordance with cGMP, GLP, DEA and ...
Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for ... Performs a variety of chemical analyses and GMP review in accordance with cGMP, GLP, DEA and ...
Senior Business Analyst
South Plainfield, NJ · On-site
$96K - $124K/yr
Data Analysis and Reporting: * Analyze safety data to identify trends, patterns, and potential risks. * Prepare and present reports to senior management, regulatory authorities, and key stakeholders.
Senior Business Analyst
South Plainfield, NJ · On-site
$96K - $124K/yr
Data Analysis and Reporting: * Analyze safety data to identify trends, patterns, and potential risks. * Prepare and present reports to senior management, regulatory authorities, and key stakeholders.
Manager, Quality Analytics
Boston, MA · On-site
This role is pivotal in driving data-driven decision-making and strategic process improvements ... Develop and implement data analyses, data collection systems, and strategies to optimize ...
Manager, Quality Analytics
Boston, MA · On-site
This role is pivotal in driving data-driven decision-making and strategic process improvements ... Develop and implement data analyses, data collection systems, and strategies to optimize ...
Overview Katalyst is seeking a highly capable, hands-on Director of Finance own the company's full ... Hire, develop, and lead future finance team members across accounting, FP&A, and AP/AR as the ...
Overview Katalyst is seeking a highly capable, hands-on Director of Finance own the company's full ... Hire, develop, and lead future finance team members across accounting, FP&A, and AP/AR as the ...
Supplier Quality Engineer
Sunnyvale, CA · On-site
Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for ... analysis, and FAIR. * Develop supplier ramp readiness based on forecast, supplier capacity, quality ...
Supplier Quality Engineer
Sunnyvale, CA · On-site
Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for ... analysis, and FAIR. * Develop supplier ramp readiness based on forecast, supplier capacity, quality ...
Data Entry Operator
Portsmouth, NH · On-site
This role directly supports MSAT, Process Analytics, Process Validation, and Investigation teams by ensuring accurate, timely, and compliant data availability for critical manufacturing operations.
Data Entry Operator
Portsmouth, NH · On-site
This role directly supports MSAT, Process Analytics, Process Validation, and Investigation teams by ensuring accurate, timely, and compliant data availability for critical manufacturing operations.
Data Entry Operator III
Portsmouth, NH · On-site
$17.25 - $23.25/hr
This role directly supports MSAT, Process Analytics, Process Validation, and Investigation teams by ensuring accurate, timely, and compliant data availability for critical manufacturing operations.
Data Entry Operator III
Portsmouth, NH · On-site
$17.25 - $23.25/hr
This role directly supports MSAT, Process Analytics, Process Validation, and Investigation teams by ensuring accurate, timely, and compliant data availability for critical manufacturing operations.
SAP Process Analyst
Santa Rosa, CA · On-site
This role will focus on process optimization, data analysis, and stakeholder collaboration within a fast-paced, regulated environment. The ideal candidate will have strong SAP expertise, analytical ...
SAP Process Analyst
Santa Rosa, CA · On-site
This role will focus on process optimization, data analysis, and stakeholder collaboration within a fast-paced, regulated environment. The ideal candidate will have strong SAP expertise, analytical ...
Strong Genomics NGS Data Analyst with algorithm development background who has the ability to support validation of bioinformatics pipelines for products being submitted to CAP, CLIA, FDA, New York ...
Strong Genomics NGS Data Analyst with algorithm development background who has the ability to support validation of bioinformatics pipelines for products being submitted to CAP, CLIA, FDA, New York ...
Data Entry Operator III
$17.25 - $23.25/hr
This role directly supports MSAT, Process Analytics, Process Validation, and Investigation teams by ensuring accurate, timely, and compliant data availability for critical manufacturing operations.
Data Entry Operator III
$17.25 - $23.25/hr
This role directly supports MSAT, Process Analytics, Process Validation, and Investigation teams by ensuring accurate, timely, and compliant data availability for critical manufacturing operations.
Data Entry Operator III
Portsmouth, NH · On-site
$17.25 - $23.25/hr
This role directly supports MSAT, Process Analytics, Process Validation, and Investigation teams by ensuring accurate, timely, and compliant data availability for critical manufacturing operations.
Data Entry Operator III
Portsmouth, NH · On-site
$17.25 - $23.25/hr
This role directly supports MSAT, Process Analytics, Process Validation, and Investigation teams by ensuring accurate, timely, and compliant data availability for critical manufacturing operations.
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.