CSV Consultant

4 weeks ago

New York, United States Katalyst Healthcares and Life Sciences Full time

Responsibilities:

Collaborating with cross-functional teams to assess, validate, and ensure the proper functioning of a custom-developed Clinical Safety Monitoring software solution.
pplying your deep understanding of regulatory requirements (FDA, EU, ICH, etc.) to the validation process, ensuring that the software meets all necessary guidelines.
Developing and executing comprehensive validation protocols and test scripts in adherence to industry standards and best practices.
Documenting validation activities, results, and deviations, and providing clear and concise reports for regulatory submissions.
Implementing risk-based methodologies to identify and address potential risks associated with the software solution.
Supporting the development and maintenance of robust Software Development Life Cycle (SDLC) documentation, including user requirements, design specifications, and test documentation.
Collaborating with internal teams to ensure that the software validation process aligns with project timelines and quality objectives.
Communicating effectively with stakeholders, project managers, regulatory bodies, and auditors as needed.
Staying current with industry trends, regulatory updates, and advancements in software validation practices.

Requirements:

Bachelor's or master's degree in a relevant scientific or engineering field.
Extensive experience (5+ years) in Computer System Validation (CSV) within the Biologics & Medical Device industry.
Proven track record of successfully validating Clinical Safety Monitoring software solutions.
Thorough understanding of regulatory requirements and guidelines relevant to the Biologics & Medical Device industry.
Strong knowledge of risk-based methodologies and their application in software validation.
Proficiency in developing and executing validation protocols and test scripts.
Experience with GxP regulations (GMP, GLP, GCP) and 21 CFR Part 11 compliance.
Excellent communication skills, both written and verbal, with the ability to collaborate effectively with cross-functional teams.
Previous experience with software tools such as Jira, and familiarity with validation documentation management systems.
Certification in relevant areas (e.g., RAPS, ASQ, PDA) is a plus.

Solutions Architect