Description

Lead end-to-end Computer System Validation (CSV) deliverables for new and existing applications across Lab, Enterprise, and Manufacturing environments.

Responsibilities

• Manage CSV deliverables including Initial System Assessments, Functional Specifications, Functional Risk Assessments, Design Documents, SOP Planning, Data Integrity Assessments, and Traceability Matrices.
• Execute IQ, OQ, and PQ protocols, interim memos, and Validation Summary Reports.
• Oversee system implementation while supporting change management processes.
• Serve as the direct interface to the customer FT team and lead CSV Consultants on execution tasks.
• Assist the Engagement Lead with resource interviews, allocation, utilization, and schedule forecasting.

Required Skills

• 5+ years of experience in CSV within ERP, Lab Systems, Automation, and Manufacturing environments.
• Proven experience managing FTEs or contractors.
• Strong project management experience with expertise in authoring Initial System Assessments and Functional Specifications.
• Proficiency in performing Functional Risk Assessments and Data Integrity Assessments.
• Experience with SOP Planning and Design Documents.
• Ability to perform QA reviews of User Requirements and SOPs.
• Bachelor's degree or equivalent graduate qualification.

Preferred Skills

• Strong internal and external communication skills.

Key Skills

Education

Any Graduate