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

Openkyber

Snowflake Engineer Job at Openkyber

...We are looking for a highly experienced Snowflake Migration Architect / Technical Lead / Senior Developer to lead the migration of large... ...data from legacy/on-prem databases into Snowflake. Re-engineer or modernize existing ETL/ELT pipelines for the Snowflake platform...

The Learning Experience

Childcare Center Director Job at The Learning Experience

...Generous PTO, child care discounts, and more! State-of-the-Art Classrooms: Lead in immersive classrooms equipped with the latest... ...monthly emergency safety drills Manages new customer administration and files in compliance with state licensing regulations Participate...

Host Healthcare

Travel Nurse RN - Emergency Room (ER) / Trauma - $1,853 to $2,006 per week in Coos Bay, OR Job at Host Healthcare

...Registered Nurse (RN) | Emergency Room (ER) / Trauma Location: Coos Bay, OR Agency: Host Healthcare Pay: $1,853 to $2,006 per week Shift Information: Nights Contract Duration: 13 Weeks Start Date: 9/29/2026 About the Position Host Healthcare...

Aetwork

Design Director Job at Aetwork

...Design Directors at Blitz champion conceptually and technically strong architecture, shaping studio culture in order produce exceptional... ...Leadership across projects, Participation in community design events, and crafting pitches for new work. During Programming, Concept,...

H&H Recruiting

CDL Driver Recent Graduate Class A CDL Truck Driver Job at H&H Recruiting

...Job Description Job Description TITLE: Recent Graduate Class A CDL Truck Driver OVER THE ROAD CLASS A DRIVERS WANTED CDL in Hand? Start Earning NOW!$1,200+ Weekly - No experience? No problem! We'll set you up for success. Home Time - Bi-weekly Regional...

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