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

aHh0RjFXeVhWTFZwWExibm94QmRzYmdydFE9PQ==
  • 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

County of Los Angeles

Election Ballot Processor & Outreach Assistant Job at County of Los Angeles

 ...problems, and distributing election materials to the public.Applicants must have a valid California Class C Driver License or alternative transportation options. No prior experience is needed, but physical abilities for light clerical work are required.#J-18808-Ljbffr... 

SonShine & Blessings

Fundraising, Marketing Volunteers Job at SonShine & Blessings

SS&B needs volunteers to initiate, implement, and manage fundraising ideas to help SS&B continue to help the community with its services. We specifically need at least one person who is willing and able to head up this very important aspect of SS&B.

Aligned Data Centers

Design Manager Job at Aligned Data Centers

 ...Design Manager - PHX It's fun to work in a company where people truly believe in what they're doing! We're committed to bringing passion and customer focus to the business. Does the thought of joining one of the fastest-growing, privately held data center companies... 

Search360

Direct Support Professional (DSP) Job at Search360

 ...Residential Direct Support Professional (DSP)Supported Living ProgramLocation: Mount Prospect, Skokie, and Morton Grove, ILAre You Passionate About Making a Positive Impact on the Lives of Others?Search360 is actively seeking dedicated and compassionate individuals... 

Apex Therapeutic Services

Registered Nurse Job at Apex Therapeutic Services

 ...Job Description Job Description School Nurse (RN) Massapequa Long Island, NY area Currently seeking long term Registered Nurses...  ...McKenna Elementary Unqua Elementary Summer School Home Based/Trip Based Assignments Responsibilities of the School Nurse...