Manager, Global Computer System Validation (CSV)

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.

Key Responsibilities of the Manager, Global CSV:

• 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.

Qualifications of the Manager, Global CSV:

• 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.

Compensation & Benefits of the Manager, Global CSV:

• Salary range: $120,000-$140,000
• Full medical, dental, vision coverage and paid time off.
• Professional development opportunities.
• Collaborative and innovative work environment.

Application Deadline: Applications will be accepted for at least 30 days from the posting date (11/12).

Keywords: CSV, CSA, GAMP 5, 21 CFR Part 11, EU Annex 11, Validation Master Plan, GMP, ERP, LIMS, ELN, SaaS, IaaS, PaaS, Risk-Based Validation, CAPA, Change Control, Audit Readiness, Pharmaceutical, Biotech, Compliance, IT Systems, Project Management, Agile, Waterfall.

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