Senior CSV Specialist - GxP Systems & Cell Therapy

Katalyst CRO; City of Rochester (NY); Vor Ort; USD 110.000 - 150.000; Vollzeit

Zusammenfassung

Katalyst CRO in Rochester, NY seeks a Senior CSV Specialist to lead validation activities for enterprise GxP systems, focusing on critical Cell Therapy projects. The role supports validation leads to ensure deliverables and testing align with the Client CSV SOP.

Effective communication across Business, IT, and Quality is essential, with experience using digital validation tools and leveraging AI as an accelerator.

Qualifikationen

• Bachelor's degree in engineering, Pharmaceutical Sciences, Chemistry, Biology, or related field.
• 8–10+ years of experience in pharmaceutical/biotech or regulated manufacturing environments.
• 5+ years in Data Integrity/ALCOA+ principles.
• 5+ years in CSA (GxP) principles.
• 5+ years of technical writing experience.
• Working knowledge of GMP, GLP, and GAMP 5 principles.
• Strong understanding of FDA, ICH guidelines, and EU Annex 11.
• Experience developing, executing, and reviewing validation protocols/reports, risk assessments, SOPs, deviations, and CAPAs.
• Ability to support regulatory inspections and audits.
• Strong technical writing skills with data integrity focus.
• Familiar with electronic document management systems (Qumas, SharePoint) and ALM/Jira.
• Excellent written and spoken English; capable of interviewing stakeholders.

Aufgaben

• Support creation, review, and approval of all CSV deliverables for in-house solutions.
• Maintain close communication with stakeholders to track CSV needs and project status.
• Create documents to existing standards.
• Obtain and respond to reviews from Business, IT, and Quality.
• Follow SOPs and industry best practices.
• Proficient in MS Office and Visio.

Kenntnisse

CSV Validation

Data Integrity/ALCOA+

Technical writing

Regulatory compliance

Cross-functional collaboration

FDA/ICH knowledge

Ausbildung

Bachelor's degree in engineering/Pharmaceutical Sciences/chemistry/biology

Tools

Qumas

SharePoint

MS Office

Visio

ALM

Jira

ServiceNow

Jobbeschreibung

Katalyst CRO in Rochester, NY seeks a Senior CSV Specialist to lead validation activities for enterprise GxP systems, focusing on critical Cell Therapy projects. The role supports validation leads to ensure deliverables and testing align with the Client CSV SOP.

Effective communication across Business, IT, and Quality is essential, with experience using digital validation tools and leveraging AI as an accelerator.