Description

You will own the validation lifecycle for manufacturing equipment and processes in a regulated environment.

This role is on-site.

Responsibilities

• Execute Installation, Operational, and Performance Qualifications (IQ/OQ/PQ) for mixers, conveyors, and packaging lines.
• Validate core manufacturing processes including blending, cutting, rolling, and packaging to ensure consistent quality.
• Write, review, and execute validation protocols and reports, ensuring strict adherence to FDA and GMP guidelines.
• Conduct risk assessments and implement corrective and preventive actions (CAPA) for equipment malfunctions or process deviations.
• Manage revalidation efforts triggered by changes in materials, equipment, or regulatory updates.

Required Skills

• 7+ years of experience in Quality or relevant process engineering within a regulatory environment.
• Deep understanding of validation methodologies, including IQ/OQ/PQ protocols and risk assessment techniques.
• In-depth knowledge of Food or Consumer industry regulations, FDA guidelines, and GMP standards.
• Bachelor’s degree in Engineering (Mechanical, Chemical, Industrial), Manufacturing, Life Sciences, or a related field.
• Experience with Manufacturing Execution Systems (MES) and Enterprise Resource Planning (ERP) systems.
• Ability to lead and manage both onshore and offshore teams effectively.
• Strong communication skills to interact with cross-functional teams, senior management, and external auditors.

Key Skills

Education

Bachelor's degree