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 ...
66 Katalyst Data Jobs Hiring Near You
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 ...
CSV Engineer
Columbus, OH ยท On-site
By maintaining data integrity and system compliance, the CSV Engineer plays a critical part in ensuring product quality, patient safety, and regulatory inspection readiness. Roles & Responsibilities:
CSV Engineer
Columbus, OH ยท On-site
By maintaining data integrity and system compliance, the CSV Engineer plays a critical part in ensuring product quality, patient safety, and regulatory inspection readiness. Roles & Responsibilities:
Quality Manager
Alexandria, OH ยท 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 ยท 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 ...
Design Engineer L2
Raymond, OH ยท Hybrid
Reference CAD data of previous program and similar programs. * Class A surface. * Guidance sections/Start parts. * Standards, Guidelines, and problem history documents. * Preliminary BOM.
Design Engineer L2
Raymond, OH ยท Hybrid
Reference CAD data of previous program and similar programs. * Class A surface. * Guidance sections/Start parts. * Standards, Guidelines, and problem history documents. * Preliminary BOM.
C&Q Engineer
New Albany, OH ยท 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 ยท 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 ...
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 ...
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 are the most popular job types at Katalyst?
What are the most popular jobs at Katalyst?
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Job description
Roles & Responsibilities:
- Lead/Support a Veeva LIMS implementation and the validation activities throughout the system lifecycle, from requirements and design through testing, deployment, and validation closeout
- Develop and/or review validation deliverables, including URS, risk assessments, validation plans, test scripts, traceability matrices, validation summary reports, and SOPs
- Partner with Quality, Laboratory, IT, Business Process Owners, and system stakeholders to define requirements and ensure the LIMS meets business and regulatory needs
- Support Veeva LIMS configuration, functional testing, integration testing, user acceptance testing, and defect resolution
- Apply risk-based CSV/CSA principles and applicable GxP requirements to ensure the validated state of the system is maintained
- 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 lifecycle activities following implementation
- Provide technical and validation expertise during implementation meetings, workshops, testing activities, and issue resolution
- Ensure validation activities comply with applicable regulatory expectations, company procedures, and industry practices such as GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles
- Support inspection and audit readiness by ensuring complete, accurate, and traceable validation documentation.
- Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related technical discipline
- 5+ years of experience in computerized system validation, quality, or validation engineering within pharmaceutical, biotechnology, or other GxP-regulated environments
- Demonstrated experience with Veeva LIMS implementation, validation, or lifecycle management
- Strong understanding of CSV/CSA methodologies, GxP requirements, risk-based validation, and data integrity
- Experience developing and executing validation/testing documentation, including requirements, risk assessments, test protocols/scripts, traceability, and validation reports
- Strong understanding of 21 CFR Part 11, EU Annex 11, GAMP 5, and applicable data integrity principles
- Strong project management, organizational, communication, and problem-solving skills