Job Description

We are seeking an experienced Manufacturing Engineer to lead capital projects, equipment validation, and continuous improvement initiatives in a regulated manufacturing environment. This role is ideal for an engineer who enjoys working cross-functionally to introduce new technologies, optimize manufacturing processes, and ensure compliance with industry regulations while supporting operational excellence.

As a Manufacturing Engineer, you'll collaborate with local and global engineering teams, Production, Quality, Maintenance, Supply Chain, and EHS to deliver innovative manufacturing solutions that improve equipment reliability, Overall Equipment Effectiveness (OEE), and product quality.

What You'll Do

• Lead CAPEX projects and new equipment introductions that improve production efficiency, reduce scrap, and support business growth.
• Manage projects from planning through implementation, including scope, schedule, budget, risk management, and stakeholder communication.
• Support equipment qualification and validation activities including URS, FMEA, IQ/OQ/PQ, Process Validation, FAT/SAT, commissioning, and startup.
• Prepare and maintain audit-ready documentation in compliance with cGMP, GDP/ALCOA+, ISO 9001, ISO 15378, and applicable regulatory requirements.
• Lead change control activities, ensuring effective implementation and closure.
• Investigate quality events including CAPAs, customer complaints, deviations, and nonconforming materials using structured root cause analysis.
• Drive Lean Manufacturing and Six Sigma initiatives to improve OEE, uptime, cycle times, and overall manufacturing performance.
• Develop and update SOPs, preventive maintenance strategies, spare parts inventories, and technical training for Production and Maintenance teams.
• Collaborate with global engineering teams on specialized automated manufacturing equipment including automated vial washing systems and depyrogenation ovens
• Vision inspection systems
• PLC-controlled automation
• Cleanroom manufacturing equipment
• Pouch sealing and vial handling systems
• Mentor engineers and technicians by promoting structured troubleshooting and best practices.
• Support occasional travel to suppliers and company facilities within the U.S. and internationally.

Qualifications

Required

• Bachelor's degree in Mechanical, Electrical, Chemical, Industrial, Manufacturing, Pharmaceutical, Materials Engineering, or a related discipline.
• Equivalent experience may be considered.
• Minimum of four years of engineering experience in a regulated manufacturing environment.
• Experience managing CAPEX projects and equipment implementation.
• Knowledge of validation methodologies including URS, FMEA, IQ/OQ/PQ, and Process Validation.
• Experience with change control, deviations, CAPA, and Quality Management Systems.
• Working knowledge of cGMP regulations, ISO 9001, and ISO 15378.
• Experience with Lean Manufacturing, Six Sigma, DMAIC, Kaizen, and root cause analysis.
• Strong project management, communication, and problem-solving skills.
• Advanced proficiency with Microsoft Office.

Preferred

• Six Sigma Green Belt or Black Belt certification.
• PMP certification.
• Experience with SAP, Microsoft Project, SolidWorks, and Minitab.
• Experience with FAT/SAT, commissioning, and new equipment startup.

If you're passionate about engineering, continuous improvement, and delivering high-quality manufacturing solutions, we'd love to hear from you.

Apply today and help shape the future of manufacturing with us.

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