Job Duties & Responsibilities:The Sr. Manufacturing Engineer - Capital Projects & Automation leads capital engineering projects and manufacturing optimization initiatives within a cGMP nutraceutical manufacturing and packaging environment. This role is responsible for delivering projects from concept through commissioning and validation, including equipment selection, installation, startup, automation integration, and process improvement. The position partners cross-functionally with Operations, Quality, Maintenance, Supply Chain, and IT to implement safe, compliant, scalable, and efficient manufacturing solutions. The ideal candidate combines strong capital project execution experience with hands-on GMP manufacturing expertise and a continuous improvement mindset.
Key Responsibilities:Capital Projects & Engineering Execution:- Lead capital projects from scoping and design through installation, commissioning, and validation (IQ/OQ/PQ)
- Develop project scopes, URS, budgets, and timelines; manage execution to meet cost, schedule, and performance targets
- Partner with equipment vendors, system integrators, and contractors to deliver robust manufacturing solutions
- Support capacity planning, line expansions, and facility upgrades aligned to business growth
- Ensure equipment, automation systems, and engineering activities comply with safety, environmental, and ergonomic standards
Manufacturing Process Optimization & Continuous Improvement - Identify and implement improvements to increase throughput, reduce waste, and improve equipment reliability
- Apply Lean principles (e.g., value stream mapping, Kanban, 5S, waste reduction) to optimize material flow and labor efficiency
- Identify and implement process improvements to increase throughput, reduce waste, improve product quality, and enhance equipment reliability
- Apply Lean Manufacturing principles (e.g., Value Stream Mapping, 5S, Kanban, waste reduction) to improve material flow, labor utilization, and operational efficiency
- Troubleshoot manufacturing processes and equipment across blending, encapsulation, tableting, and packaging operations using structured root-cause problem solving
- Drive improvements in line efficiency, changeover performance, equipment uptime, and Overall Equipment Effectiveness (OEE)
- Utilize digital manufacturing tools, data analytics, and emerging AI-enabled technologies to improve labor efficiency, equipment utilization, and manufacturing performance.
- Analyze manufacturing performance data and KPIs to identify root causes of efficiency losses during shift changes, changeovers, and production interruptions.
- Drive improvements in changeover performance, line efficiency, and OEE
Automation & Manufacturing Systems- Lead or support implementation of automated manufacturing systems, including packaging automation, PLC/HMI/SCADA integration, and equipment controls
- Partner with controls engineers and integrators to ensure reliable, scalable, and maintainable system design
- Support lifecycle management of manufacturing systems, including upgrades and obsolescence planning
- Support integration of manufacturing systems with MES, ERP, or data collection platforms where applicable
Cross-Functional Leadership- Lead cross-functional teams across Operations, Quality, Maintenance, Supply Chain, and IT
- Drive alignment and decision-making to successfully deliver projects in a live GMP environment
- Serve as the technical owner for assigned projects and initiatives
GMP Compliance & Validation- Execute engineering activities in compliance with cGMP, change control, and validation requirements
- Lead equipment qualification and process validation efforts (IQ/OQ/PQ)
- Support internal and external audits, representing engineering systems and processes
Qualifications:Education: Bachelor's degree in Engineering required (Mechanical, Chemical, Electrical, Industrial or related). Advanced degree (e.g., MS in Engineering or Engineering Management) preferred, particularly for candidates with experience in automation, data analytics, or advanced manufacturing systems.
Experience:- 5+ years of progressive engineering experience in a regulated (cGMP) manufacturing environment
- Demonstrated success leading capital projects from concept through commissioning and validation (IQ/OQ/PQ)
- Experience driving manufacturing efficiency improvements and cross-functional process optimization initiatives
Technical Skills:- Hands-on experience implementing equipment and process changes within cGMP manufacturing environments
- Working knowledge of change control, deviation management, equipment qualification, and validation (IQ/OQ/PQ)
- Strong troubleshooting and root-cause problem-solving skills related to manufacturing processes and equipment
- Experience supporting automation systems, controls integration, robotics, or packaging automation preferred
- Ability to effectively support regulatory inspections and partner with Quality and Regulatory teams during audits
Process Expertise:- Practical application of Lean Manufacturing principles (e.g., VSM, 5S, waste reduction) to support process optimization and capacity improvements.
Digital Literacy:- Experience working with manufacturing automation systems including PLCs, HMIs, SCADA, robotics, or packaging automation systems
- Familiarity with manufacturing data analytics, digital manufacturing tools, and AI-enabled process optimization technologies preferred
Physical Requirements:
- Ability to work in a manufacturing environment and provide occasional off-shift or weekend project support as needed
