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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 audits and support continuous improvement projects across engineering and validation functions.
* Communicate progress and challenges effectively to management and team members.
Skills and Experience:
* Experience in project management and/or quality engineering within a GMP-regulated manufacturing setting.
* Strong understanding of GMP compliance, equipment validation, and engineering change management.
* Ability to manage project documentation, budgets, and schedules.
* Problem-solving skills with a proactive approach to continuous improvement.
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