Quality Systems Engineer

Katalyst-Healthcares-; Swiftwater (Monroe County); On-site; USD 85,000 - 130,000; Full time

Job summary

The Katalyst-Healthcares- Quality Systems Engineer will support pharmaceutical manufacturing operations, focusing on Formulation and Filling, in Monroe County, Swiftwater, PA. You will drive CAPA, Change Control, quality investigations, and root cause analysis while ensuring cGMP compliance.

You will collaborate across Quality, Operations, Engineering, MSAT and Sterility Assurance to enable continuous improvement using Lean, Six Sigma, and visual management principles, with strong technical

Qualifications

• Bachelor's degree in a relevant science or engineering field.
• Minimum 3–5 years in pharmaceutical manufacturing or Quality Systems.
• Strong knowledge of cGMP and regulatory requirements.

Responsibilities

• Lead CAPA and Change Control actions with timely closure.
• Perform quality investigations and root cause analyses.
• Collaborate with cross-functional teams to resolve issues.
• Provide technical support for eBR, OEE, and qualification activities.
• Contribute to Lean and Six Sigma continuous improvement.
• Prepare and maintain protocols, investigations, and change controls.

Skills

Cross-functional communication

Problem-solving

Project management

Education

Bachelor's degree

Tools

Excel

Word

PowerPoint

iShift

Qualipso

eBR

Opstrakker

Job description

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.