Manager, Global Computer System Validation (CSV)

ZP Group•Durham, NC

31d•$120,000 - $140,000

About The Position

Piper Companies is seeking a detail-oriented and experienced Manager, Global CSV to lead the global validation and software assurance strategy for IT-based systems across our facilities. This role is both strategic and hands-on, focusing on transforming, executing, and sustaining a risk-based Global Validation program to ensure compliance with GMP activities and global regulatory standards.

Requirements

Bachelor's degree in a technical/science/mathematical field required.
5-8 years of validation experience in a biotech/pharmaceutical environment.
Minimum 1 year managing a validation functional area.
Experience with SaaS, IaaS, and PaaS software implementations.
Familiarity with enterprise systems such as ERP (Oracle), LIMS, ELN, CRM, LMS.
Strong understanding of GAMP 5, 21 CFR Part 11, EU Annex 11, and CSA principles.
Proficiency in creating and managing validation documentation (URS, FS, DS, IQ/OQ/PQ, traceability matrix).
Experience with risk-based validation, deviation/CAPA management, and change control systems.
Familiarity with project management tools (MS Project, JIRA, Smartsheet) and Agile/Waterfall methodologies.
Strong technical writing and audit readiness skills.
Previous leadership experience required.

Responsibilities

Develop and manage CSV lifecycle documentation, including Validation Plans, URS, FS, DS, IQ/OQ/PQ protocols, and Summary Reports.
Ensure validation activities meet FDA, EMA, and other global regulatory standards.
Lead validation efforts for systems such as eQMS, EMS, ERP (Oracle), and other GMP-critical platforms.
Author and maintain Validation Master Plans for Global Computerized Systems.
Validate integration points between automation systems and enterprise platforms (e.g., MES ERP, MES LIMS).
Conduct risk assessments and implement CSA principles to streamline validation for low-risk systems.
Promote CSA methodologies to reduce documentation burden and enhance testing efficiency.
Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, and internal SOPs.
Lead investigations and CAPAs related to system failures or deviations.
Support internal audits and regulatory inspections by providing validation documentation and system evidence.
Coordinate validation schedules, resource allocation, and project timelines.
Train and mentor staff on CSV, CSA, and compliance best practices.
Review and approve change control requests impacting validated systems.
Lead initiatives to enhance validation efficiency and system reliability.