About the Company
Our client is a leading global biopharmaceutical organization focused on developing and manufacturing innovative therapies that improve and save lives. Operating in a highly regulated GMP environment, the company combines advanced science, engineering excellence, and continuous improvement initiatives to support large-scale manufacturing operations. To strengthen its Engineering, Validation, and Maintenance (EVM) organization, they are looking for a Senior Quality Engineer who will drive quality, compliance, and process excellence initiatives across a complex technical environment.
Role Description
As Senior Quality Engineer, you will be part of a multidisciplinary Engineering, Validation, and Maintenance organization and report directly to the Compliance Supervisor. You will act as the key quality representative for the department, ensuring maintenance, engineering, validation, and qualification activities are executed in compliance with GMP regulations and internal quality standards. In addition, you will play a leading role in driving process excellence initiatives, continuous improvement programs, and Lean methodologies to improve operational performance, quality systems, and organizational effectiveness.
Key Responsibilities
- Act as the quality representative for the Engineering, Validation, and Maintenance organization.
- Ensure compliance of maintenance, engineering, validation, and qualification activities with GMP and regulatory requirements.
- Lead and support continuous improvement and process excellence initiatives across the department.
- Provide expert guidance on validation, qualification, deviations, CAPAs, events, and quality investigations.
- Support engineering and maintenance teams in applying Lean, Six Sigma, and process excellence methodologies.
- Develop and maintain performance metrics, dashboards, and quality indicators to monitor departmental performance.
- Lead and support internal audits, quality assessments, and compliance improvement activities.
- Perform risk assessments and provide guidance on GMP, Annex 11, validation, and qualification requirements.
- Collaborate with cross-functional stakeholders to improve processes, communication, and operational effectiveness.
- Drive sustainable improvements in quality systems, compliance processes, and organizational performance.
Requirements
- Bachelor's degree in Mechanical Engineering, Electrical Engineering, Process Engineering, Installation Technology, or a related technical discipline.
- 5+ years of experience in a Quality Engineering, Compliance, Validation, or Process Excellence role.
- Strong experience within a GMP-regulated pharmaceutical, biotechnology, life sciences, or process industry environment.
- Solid understanding of validation, qualification, GMP compliance, Annex 11, CAPA management, deviations, and risk assessments.
- Experience with Process Excellence, Lean, Six Sigma, or continuous improvement methodologies.
- Green Belt and/or Yellow Belt certification is highly preferred.
- Knowledge of pharmaceutical regulations and industry standards such as FDA, GMP, ICH, ASTM, and ISPE.
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