Production Engineer

Senior Production Engineer / System Owner

Our client, a leading pharmaceutical manufacturer, is seeking a Senior Production Engineer / System Owner to support manufacturing operations with a strong focus on equipment compliance, process reliability, and continuous improvement.

Key Responsibilities

• Lead the integration of new equipment and technology into manufacturing operations.

• Drive LEAN and continuous improvement initiatives by identifying inefficiencies and eliminating non-value-added activities.

• Ensure GMP compliance through proactive change management, qualification, and validation of equipment and processes.

• Spend significant time on the production floor across shifts, supporting hands-on troubleshooting and engineering solutions.

• Participate in planning and coordination of maintenance and shutdown activities.

• Collaborate with cross-functional teams including Manufacturing, QA, QC, EHS, and Engineering.

• Support project execution and capital planning, contributing to equipment layout, preventive maintenance, and validation activities.

• Monitor system performance (OEE, yield, reliability) and develop plans for repair, replacement, and strategic lifecycle management.

• Act as a technical resource for production engineers and provide operational support when needed.

Qualifications

• Bachelor's degree in Mechanical, Chemical, or Manufacturing Engineering (or equivalent).

• 6+ years (with BS) or 4+ years (with MS) of relevant experience in pharmaceutical, food, or chemical industries.

• Strong knowledge of GMP, FDA regulations, and plant maintenance systems.

• Experience with reliability programs, audits, investigations, and technical report writing.

• Proficiency with Microsoft Office, SAP, Trackwise, and other engineering tools.

• Familiarity with problem-solving tools (Six Sigma, DOE, 8D, Fishbone, SPC).

Core Competencies

• Strong verbal and written communication

• Effective collaboration and cross-functional teamwork

• Problem-solving and results-oriented mindset

• Adaptability and action-oriented leadership

• Ability to drive engagement and instill trust

This is an excellent opportunity to play a key role in maintaining high standards of production reliability, quality, and compliance for a growing pharmaceutical manufacturing site.

Applicants must be authorized to work in the United States. Sponsorship is not available for this position.