Computer System Validation Engineer Job at Katalyst Healthcares and Life Sciences, New Wilmington, PA

  • Katalyst Healthcares and Life Sciences
  • New Wilmington, PA

Job Description

Job Summary:
  • Experienced CSV (Computer System Validation) Consultant with expertise in GxP-compliant environments to support validation, compliance, and audit readiness across life sciences systems.
  • Strong experience in CSV processes, regulatory frameworks, validation documentation, and exposure to clinical and regulatory domains.
Roles & Responsibilities:
  • Perform Computer System Validation (CSV) activities aligned with 21 CFR Part 11 / 820, GxP, GAMP 5, SOX, EU Annex 11 / Annex 22, ISO 9001, and ITIL.
  • Ensure audit and inspection readiness.
  • Conduct periodic reviews, access roster reviews, and audit trail reviews.
  • Manage deviations, CAPA processes, SOP, and policy compliance.
  • Author and review URS / FS documents, validation protocols, validation plans & reports, and final summary reports.
  • Perform risk-based validation and testing aligned with CSA (Computer Software Assurance).
  • Support validation lifecycle from planning to execution and closure.
  • Work with platforms such as Veeva Vault Suite, LabWare LIMS, SAP (GxP modules), and BIOVIA Electronic Lab Notebook.
  • Collaborate with teams across Biostatistics, Clinical & Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, Manufacturing, Quality, and TechOps.
Education & Experience:
  • 8-10 years of experience in Computer System Validation (CSV).
  • Strong knowledge of GxP regulations, validation frameworks, GAMP 5, and CSA principles.
  • Experience with CAPA, deviation management, SOP, and policy compliance.
  • Strong documentation and validation lifecycle experience.
  • Good understanding of life sciences domain processes.

Job Tags

Similar Jobs

Urban Outfitters

Anthropologie On-Model Studio Intern Job at Urban Outfitters

 ...On Model Studio Intern Anthropologie is looking for an On Model Studio Intern to join our team for the summer. We're looking for someone...  .... Please include models you think best represent the Anthro brand, including casting decisions, shoot locations, art direction... 

CAI

Computer Systems Validation Engineer Job at CAI

 ...We provide commissioning, qualification, validation, startup, project management, and other...  ...Documentation & Compliance Author GxP computer validation documentation (e.g., URS, FRS...  ...plans and risk assessments System & Industry Expertise Support CSV activities... 

LocumTenens.com

Vascular/Interventional Radiologist Needed for Locum Coverage at InpatientFacility in Rockville, Maryland Job at LocumTenens.com

 ...inpatient hospital located in Rockville, Maryland provides interventional radiology services utilizing McKesson PACS and Philips IR equipment...  ...About the Clinician's Workday The vascular/interventional radiologist will provide on-site inpatient coverage Monday through... 

Airport Security Careers

Lead / Supervisory Transportation Security Officer - No Experience RequiredforEntry-Level TSA Career Job at Airport Security Careers

 ...Role Overview TSA is accepting applications for Lead and Supervisory Transportation Security Officers at airports in Diablo. These roles are ideal for individuals looking to step into leadership positions within airport security operations. TSA provides training to... 

Stio

Apparel/Outerwear Fit Model - Contractor | Multiple Locations Needed Job at Stio

 ...About UsStio is an omni-channel mountain brand that designs, develops and sells beautiful, functional, and innovative apparel, footwear...  ...POSITION - 3 Hrs Per MonthStio is looking for a part-time Fit Model contractor to assist Stio's Product Development Team at an...