Job Title: Project/Quality Engineer

Role Purpose:

The Project/Quality Engineer will play a key role in delivering engineering projects and ensuring quality and compliance within a regulated manufacturing environment. This role involves managing capital projects, supporting equipment validation, and driving continuous improvement to enhance safety, quality, and operational efficiency.

Key Responsibilities:

Manage and deliver engineering projects including process, packaging, and civil upgrades on time and within budget. Prepare project scopes, financial justifications, and detailed plans; monitor contractors and oversee project execution. Support manufacturing operations by optimizing equipment performance and adopting new technologies. Coordinate and lead validation and revalidation activities for GMP-critical equipment, ensuring compliance with regulatory standards. Oversee engineering change controls, CAPAs, and quality documentation related to validation and operational equipment. Develop, execute, and report on validation protocols and qualification requirements (URS, DQ, FAT, IQ, OQ, PQ). Maintain a safe work environment by identifying hazards, reporting incidents, and promoting safety best practices. Contribute to risk assessments, root cause analysis, and continuous improvement initiatives targeting efficiency, cost reduction, quality enhancement, safety, flexibility, and delivery performance. Participate in internal audit...