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.
We offer medical, dental, vision and company matching 401K.
