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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

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

Medical Writer

Paramus, NJ · On-site

We are seeking a skilled Medical Writer to develop high-quality clinical and regulatory documents in compliance with industry standards and regulatory guidelines. * The ideal candidate will ...

Katalyst

Medical Writer

Titusville, NJ · On-site

The Contractor Medical Writer, Medical Information, Payer and Health Systems report to the Associate Director/Director Med Info-PHS and supports the development and dissemination of Medical ...

Katalyst Surgical "a ZEISS Company

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Surgical Instrument Technician

Chesterfield, MO · On-site

$19/hr

Medical * Vision * Dental * 401k Matching * Employee Assistance Programs * Vacation and sick pay ... Learn more about the Katalyst history below, including what inspired the famous Katalyst logo ...

Katalyst Surgical "a ZEISS Company

Be Seen First

Surgical Instrument Technician

Chesterfield, MO · On-site

$19/hr

Medical * Vision * Dental * 401k Matching * Employee Assistance Programs * Vacation and sick pay ... Learn more about the Katalyst history below, including what inspired the famous Katalyst logo ...

Katalyst CRO

Regulatory Affairs Manager

Boston, MA

Regulatory Affairs Manager - Katalyst CRO Join to apply for the Regulatory Affairs Manager role at ... Developing regulatory strategies for existing, new, and modified medical devices and other ...

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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.
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CSV Engineer

CSV Engineer

Katalyst

Columbus, OH • On-site

Other

Posted 21 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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