CSV Lead

Cynet Systems•Jersey City, NJ

About The Position

The CSV Lead will be responsible for leading and executing Computer System Validation (CSV) activities for GxP-regulated applications within pharmaceutical or life sciences environments. This role involves developing and reviewing various validation documents, supporting manufacturing and labeling systems, and ensuring compliance with regulatory requirements. The lead will collaborate with cross-functional teams and provide validation guidance throughout project lifecycles.

Requirements

Strong Computer System Validation experience.
Hands-on experience in regulated pharmaceutical or life sciences environments.
Experience with validation lifecycle documentation.
Strong understanding of manufacturing execution and shop-floor processes.
Knowledge of labeling systems and related validation requirements.
Experience supporting manufacturing applications.
Expertise in IQ/OQ/PQ execution.
Experience with risk-based validation approach.
Experience with traceability management.
Experience with defect management and test coordination.
Knowledge of GxP compliance.
Knowledge of FDA 21 CFR Part 11.
Knowledge of GAMP5.
Knowledge of Data Integrity principles (ALCOA+).
Experience with Change Control and CAPA processes.
Strong verbal and written communication skills.
Ability to communicate effectively with stakeholders.
Experience working in global delivery models.

Nice To Haves

Experience with MES systems (Werum PAS-X, Syncade, etc.).
Experience with labeling platforms (Loftware, NiceLabel, Bartender).
Experience with SAP and manufacturing integrations.
Agile delivery experience.
Audit and inspection support experience.

Responsibilities

Lead and execute Computer System Validation activities for GxP-regulated applications.
Develop and review validation deliverables including Validation Plans, Risk Assessments, and User Requirement Specifications (URS).
Develop and review Functional Specifications, IQ/OQ/PQ Protocols, Traceability Matrices, and Validation Summary Reports.
Support validation of manufacturing and labeling systems.
Perform impact assessments, change control assessments, and periodic reviews.
Collaborate with Quality, Manufacturing, Regulatory, Business, and IT teams.
Ensure compliance with FDA, GAMP5, 21 CFR Part 11, Annex 11, and applicable regulatory requirements.
Coordinate testing activities and review test evidence.
Support audits, inspections, and compliance initiatives.
Provide validation guidance throughout system implementation and enhancement projects.