... 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 ...
61 Katalyst Medical Writer Jobs Hiring Near You
... 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 ...
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 ...
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 ...
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 ...
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 ...
Company Description The Klick Group -comprising Klick Health (including Klick Katalyst and btwelve ... Klick is hiring a Senior Medical Writer to develop scientifically accurate, strategically aligned ...
Company Description The Klick Group -comprising Klick Health (including Klick Katalyst and btwelve ... Klick is hiring a Senior Medical Writer to develop scientifically accurate, strategically aligned ...
Company Description The Klick Group --comprising Klick Health (including Klick Katalyst and btwelve ... Klick is hiring a Senior Medical Writer to develop scientifically accurate, strategically aligned ...
Quick apply
Company Description The Klick Group --comprising Klick Health (including Klick Katalyst and btwelve ... Klick is hiring a Senior Medical Writer to develop scientifically accurate, strategically aligned ...
Company Description The Klick Group -comprising Klick Health (including Klick Katalyst and btwelve ... Klick is hiring a Senior Medical Writer to develop scientifically accurate, strategically aligned ...
Company Description The Klick Group -comprising Klick Health (including Klick Katalyst and btwelve ... Klick is hiring a Senior Medical Writer to develop scientifically accurate, strategically aligned ...
Company Description The Klick Group --comprising Klick Health (including Klick Katalyst and btwelve ... Klick is hiring a Senior Medical Writer to develop scientifically accurate, strategically aligned ...
Quick apply
Company Description The Klick Group --comprising Klick Health (including Klick Katalyst and btwelve ... Klick is hiring a Senior Medical Writer to develop scientifically accurate, strategically aligned ...
Senior Medical Writer - Medical Communications
Philadelphia, PA · Hybrid
$110K/yr
Company Description The Klick Group -comprising Klick Health (including Klick Katalyst and btwelve ... Klick is hiring a Senior Medical Writer to develop scientifically accurate, strategically aligned ...
Senior Medical Writer - Medical Communications
Philadelphia, PA · Hybrid
$110K/yr
Company Description The Klick Group -comprising Klick Health (including Klick Katalyst and btwelve ... Klick is hiring a Senior Medical Writer to develop scientifically accurate, strategically aligned ...
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 • ...
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 • ...
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 ...
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 Healthcares & Life Sciences is hiring entry level candidates for several positions for ... Medical Writing, Pharmacovigilance, Clinical Operations, Medical Affairs, etc. * Ability to ...
Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for ... Medical Writing, Pharmacovigilance, Clinical Operations, Medical Affairs, etc. * Ability to ...
Electrical Engineer (EPS), Spacecraft
Broomfield, CO · On-site
$105K - $145K/yr
Experience writing or executing test procedures, documenting results, and driving board- or ... medical, vision, and dental coverage, and unlimited Paid Time Off. At Katalyst our work on projects ...
Electrical Engineer (EPS), Spacecraft
Broomfield, CO · On-site
$105K - $145K/yr
Experience writing or executing test procedures, documenting results, and driving board- or ... medical, vision, and dental coverage, and unlimited Paid Time Off. At Katalyst our work on projects ...
Senior Space Systems Engineer
Broomfield, CO · On-site
$130K - $180K/yr
Strong written and verbal communication skills * Capable of identifying and solving complex ... medical, vision, and dental coverage, and unlimited Paid Time Off. At Katalyst our work on projects ...
Senior Space Systems Engineer
Broomfield, CO · On-site
$130K - $180K/yr
Strong written and verbal communication skills * Capable of identifying and solving complex ... medical, vision, and dental coverage, and unlimited Paid Time Off. At Katalyst our work on projects ...
Senior Space Systems Engineer
$130K - $180K/yr
Strong written and verbal communication skills * Capable ofidentifyingand solving complex problems ... medical, vision, and dental coverage, and unlimited Paid Time Off. At Katalyst our work on projects ...
Senior Space Systems Engineer
$130K - $180K/yr
Strong written and verbal communication skills * Capable ofidentifyingand solving complex problems ... medical, vision, and dental coverage, and unlimited Paid Time Off. At Katalyst our work on projects ...
Electrical Engineer (EPS), Spacecraft
$105K - $145K/yr
Experience writing or executing test procedures, documenting results, and driving board- or ... medical, vision, and dental coverage, and unlimited Paid Time Off. At Katalyst our work on projects ...
Electrical Engineer (EPS), Spacecraft
$105K - $145K/yr
Experience writing or executing test procedures, documenting results, and driving board- or ... medical, vision, and dental coverage, and unlimited Paid Time Off. At Katalyst our work on projects ...
Capture Manager
$110K - $180K/yr
Excellent written and verbal communication skills Preferred * Experience in government contracting ... medical, vision, and dental coverage, and unlimited Paid Time Off. At Katalyst our work on projects ...
Capture Manager
$110K - $180K/yr
Excellent written and verbal communication skills Preferred * Experience in government contracting ... medical, vision, and dental coverage, and unlimited Paid Time Off. At Katalyst our work on projects ...
Product Manager, SDA Software Applications
$120K - $170K/yr
Strong written and verbal communication skills with experience presenting to technical and ... medical, vision, and dental coverage, and unlimited Paid Time Off. At Katalyst our work on projects ...
Product Manager, SDA Software Applications
$120K - $170K/yr
Strong written and verbal communication skills with experience presenting to technical and ... medical, vision, and dental coverage, and unlimited Paid Time Off. At Katalyst our work on projects ...
Laboratory Technician
$20.25 - $26.75/hr
Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for ... medical devices. * We have a few immediate job opportunities available in Drug Safety and ...
Laboratory Technician
$20.25 - $26.75/hr
Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for ... medical devices. * We have a few immediate job opportunities available in Drug Safety and ...
Company Description The Klick Group-comprising Klick Health (including Klick Katalyst and btwelve ... Our work spans medical writing, strategy, and innovation to support impactful, compliant, and ...
Company Description The Klick Group-comprising Klick Health (including Klick Katalyst and btwelve ... Our work spans medical writing, strategy, and innovation to support impactful, compliant, and ...
Company Description The Klick Group--comprising Klick Health (including Klick Katalyst and btwelve ... Our work spans medical writing, strategy, and innovation to support impactful, compliant, and ...
Quick apply
Company Description The Klick Group--comprising Klick Health (including Klick Katalyst and btwelve ... Our work spans medical writing, strategy, and innovation to support impactful, compliant, 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.
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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.