MANUFACTURING ENGINEER

**Manufacturing & Equipment Support** - 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. **Process Engineering & Continuous Improvement** - 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. **Quality & Validation** - 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. **Qualifications** - 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. At LGM Pharma, we always take pride in putting our people first. We are an equal opportunity employer. We offer medical, dental, vision and company matching 401K. All suitably qualified candidates will receive consideration for employment based on objective work-related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws.