MANUFACTURING ENGINEER

LGM Pharma, LLC•Rosenberg, TX

26d•$80,000 - $100,000

About The Position

The Manufacturing Engineer will provide technical leadership in troubleshooting manufacturing and packaging equipment to minimize downtime and improve equipment reliability. This role involves analyzing manufacturing performance data to increase throughput, labor efficiency, and Overall Equipment Effectiveness (OEE). The engineer will lead Root Cause Analysis (RCA) investigations and implement sustainable corrective actions. Additionally, the position entails leading the installation, commissioning, startup, and qualification of new manufacturing and packaging equipment, as well as developing and reviewing User Requirement Specifications (URS) and supporting Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT). Maintaining equipment lifecycle documentation and ensuring equipment readiness are key responsibilities. The role also supports new product introductions, process scale-up, technology transfers, process validation, and customer, regulatory, and internal audits. Furthermore, the Manufacturing Engineer will develop, optimize, and standardize manufacturing processes, conduct engineering studies to improve capacity and reduce waste, monitor KPIs, and lead Lean Manufacturing, Kaizen, Six Sigma, and 5S initiatives. The engineer will also develop and revise manufacturing work instructions and SOPs, support equipment qualification and validation activities (IQ/OQ/PQ), prepare and review qualification protocols and reports, and participate in deviation investigations, CAPA implementation, and change control activities. Ensuring engineering documentation complies with FDA and cGMP requirements is also a critical aspect of this role.

Requirements

Bachelor's degree in Mechanical, Chemical, Industrial, Manufacturing, Electrical Engineering, or a related engineering discipline.
Five (5) or more years of engineering experience in pharmaceutical manufacturing or another regulated industry.
Working knowledge of FDA regulations and current Good Manufacturing Practices (cGMP).
Experience with equipment qualification, process validation, and cleaning validation.
Experience with pharmaceutical liquids, semi-solids, and/or packaging operations.
Knowledge of Lean Manufacturing, Six Sigma, and 5S methodologies.
Experience with technology transfers, change control, deviation investigations, and CAPA.
Experience using SAP or another ERP system.
Strong analytical, problem-solving, root cause analysis, technical writing, and communication skills.
Demonstrated ability to lead cross-functional teams and manage multiple priorities.

Responsibilities

Provide technical leadership in Troubleshooting manufacturing and packaging equipment to minimize downtime and improve equipment reliability.
Analyze manufacturing performance data to increase throughput, labor efficiency, and Overall Equipment Effectiveness (OEE).
Lead Root Cause Analysis (RCA) investigations for manufacturing issues and implement sustainable corrective actions.
Lead installation, commissioning, startup, and qualification of new manufacturing and packaging equipment.
Develop and review User Requirement Specifications (URS), and support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
Maintain equipment lifecycle documentation and ensure equipment remains qualified and production ready.
Support new product introductions, process scale-up, technology transfers and process validation activities.
Support customer, regulatory, and internal audits.
Develop, optimize, and standardize manufacturing processes.
Analyze manufacturing trends and KPI’s to identify opportunities for process optimization and cost reduction.
Conduct engineering studies to improve capacity, cycle times, manufacturing flow, and reduce waste.
Monitor manufacturing KPIs and identify opportunities to improve efficiency and reduce costs.
Lead Lean Manufacturing, Kaizen, Six Sigma, and 5S initiatives.
Develop and revise manufacturing work instructions and SOPs.
Support equipment qualification and process and cleaning validation activities, including IQ/OQ/PQ.
Prepare and review qualification protocols and reports.
Participate in deviation investigations, root cause analysis, CAPA implementation, and change control activities.
Support execution of Validation Master Plan activities and remediation of legacy equipment documentation.
Ensure engineering documentation complies with FDA and current Good Manufacturing Practice (cGMP) requirements.