PharmEng Technology ยท 5 days ago
Production Engineer
PharmEng Technology is a leading pharmaceutical manufacturer, and they are seeking a Senior Production Engineer / System Owner to support manufacturing operations with a strong focus on equipment compliance, process reliability, and continuous improvement. The role involves leading the integration of new equipment and driving LEAN initiatives to ensure compliance and efficiency in production processes.
ConsultingInformation TechnologyPharmaceutical
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
Qualification
Required
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)
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
Applicants must be authorized to work in the United States. Sponsorship is not available for this position