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61 Katalyst Medical Writer Jobs Hiring Near You

Katalyst

CSV Engineer

Columbus, OH · On-site

... medical device). * Working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity ... Strong technical writing skills and ability to execute protocols with minimal supervision. * Nice ...

Katalyst

Medical Writer

Norwood, MA · On-site

Serve as the medical writing Lead contributing to a variety of clinical documents for clinical and regulatory purposes, including clinical protocols, clinical study reports, investigator brochures ...

Katalyst CRO

CSV Engineer

Redwood City, CA · On-site

Katalyst CRO is looking for an experienced and well-rounded CSV (Computer System Validation ... writing test scripts • Managing change controls including creation, execution, and closure • ...

Katalyst CRO

IT Project Manager

Portsmouth, NH · On-site

$100K - $118K/yr

Katalyst CRO is a company focused on delivering IT solutions, and they are seeking an IT Project ... verbal and written). • Ability to quickly learn new software and tools. • Proficient in ...

Katalyst Space Technologies

GNC Engineer

Broomfield, CO · On-site

$90K - $150K/yr

Excellent communication skills both written and verbal Additional Requirements : Must be willing to ... medical, vision, and dental coverage, and unlimited Paid Time Off. At Katalyst our work on projects ...

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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.

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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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CSV Engineer

Katalyst

Columbus, OH • On-site

Other

Re-posted 10 days ago

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.
Roles & Responsibilities:
  • 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.
Education & Experience:
  • 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.

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