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

Astronautics

Mechanical Engineering Intern Job at Astronautics

 ...Join our Oak Creek, WI team as a Mechanical Engineering Intern ! Our internships are hands on, highly technical, and designed to let you see what it's like to work at Astronautics. This is a paid undergraduate intern opportunity. As an engineering intern, you will work... 

Lima One Capital LLC

Human Resources Intern Job at Lima One Capital LLC

 ...HR InternKickstart your career in people operations as Lima One Capital's HR Intern, where you'll gain hands-on experience across the full spectrum of HR - from payroll and compensation to employee relations, learning and development, employee engagement, and day-to-day... 

Favor

Technical Recruiter (Contract) Job at Favor

 ...unlimited) and ample vacation time to all team members. Learning and development: We encourage personal growth and education through Intern(al)ships and Learning Labs taught by Favor team members and external facilitators. Community: Whether youre an avid cyclist,... 

ARR Healthcare

Physician Assistant (PA) - Dermatology in Missouri Job at ARR Healthcare

 ...Physician Assistant | Dermatology Location: Missouri Employer: ARR Healthcare Pay: Competitive weekly pay (inquire for details) Start Date: ASAP About the Position Private Dermatology practice, located in an upscale St. Louis, MO suburb, adding... 

C3 Corporation

Mechanical Engineering Intern Job at C3 Corporation

 ...C is an engineering and manufacturing company, designing and innovating machines used in...  ...passionate about work and life. The Mechanical Engineering Intern at C3 will gain experience...  ...or senior standing at the time of the internship Additional classwork or experience...