Job Description

CSV Engineer


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Role Purpose

The CSV Engineer will be responsible for ensuring compliance, validation, and operational excellence of execution systems in line with corporate strategy, regulatory standards, and quality requirements. This role combines technical expertise, project leadership, and cross-functional collaboration to support site operations and continuous improvement initiatives.

Key Responsibilities

Strategy & Roadmap

Support the development and execution of system roadmaps aligned with corporate and site strategy.

Operations

Manage day-to-day system operations, monitor KPIs, and drive process improvements.

Quality & Compliance

Ensure adherence to GMP, QMS, IT, and EHSS requirements; lead resolution of audit findings and compliance issues.

Validation

Lead CSV activities, including requirements gathering, design, testing, and validation of execution systems.

Project Management

Deliver projects on time and within budget, applying QMS project methodology.

Vendor & Resource Management

Support vendor selection, SLA management, and oversee internal/external resources.

Business Partnership

Work with stakeholders to understand processes, build business cases, and support demand planning.

Leadership

Mentor and develop team members, foster a culture of continuous improvement, and ensure alignment with organizational values.

Qualifications

Bachelors degree in IT, Automation, Science, or Engineering (Masters preferred). 7+ years of relevant automation/CSV experience, including 3+ years in leadership or supervisory roles. Strong knowledge of GMP, regulatory compliance, and validation methodologies. Proven experience in project management, vendor management, and cross-functional collaboration. Proficiency with Microsoft Office tools (Project, PowerPoint, Visio).
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