Quality Systems Engineer

Position Summary:

The Quality Systems Engineer will provide dedicated support to pharmaceutical manufacturing operations, with a primary focus on Formulation and Filling.

This position will partner with Quality, Operations, Engineering, MSAT, Sterility Assurance, and other cross-functional teams to drive CAPA, Change Control, quality investigations, root cause analysis, and continuous improvement initiatives while maintaining compliance with cGMP and regulatory requirements.

Key Responsibilities:

• Serve as the CAPA and Change Control point of contact supporting Formulation and Filling improvement initiatives.
• Independently manage CAPA and Change Control actions, ensuring accurate documentation and timely closure.
• Lead quality investigations, troubleshooting, root cause analysis, product impact assessments, and corrective/preventive actions.
• Partner with SMEs and cross-functional stakeholders to resolve manufacturing and quality issues.
• Provide technical support for component qualification, Overall Equipment Effectiveness (OEE), electronic Batch Records (eBR), Opstrakker, and factory improvement initiatives.
• Support continuous improvement efforts utilizing Lean Manufacturing, Six Sigma, and +QDCI Visual Management principles.
• Monitor and communicate key performance metrics and identify opportunities for process improvement.
• Author and maintain high-quality protocols, technical reports, investigations, CAPAs, and Change Controls.
• Ensure compliance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and applicable regulatory requirements.
• Support regulatory inspections and audits as required.

Education and Experience:

• Minimum Education: Bachelor's degree.
• Experience: Minimum 3 5 years of relevant experience in pharmaceutical manufacturing, Quality Systems, Continuous Improvement, or a related regulated environment.
• Strong knowledge of cGMP requirements and pharmaceutical manufacturing operations.
• Experience with formulation, filling, lyophilization, and/or inspection processes.
• Experience managing CAPAs, Change Controls, quality investigations, and root cause analysis.
• Knowledge of Lean Manufacturing and Six Sigma methodologies.
• Strong technical writing, project management, problem-solving, and cross-functional communication skills.
• Proficiency in Microsoft Excel, Word, and PowerPoint.
• Experience with iShift, Qualipso, eBR, and Opstrakker preferred.