Sr Manufacturing Engineer

Duration: 12-Month Contract

Schedule: Full-Time, 40 Hours/Week

Work Arrangement: 100% Onsite (5 Days/Week)

Compensation: Competitive Bid

We are seeking a Manufacturing Engineer to support a large-scale manufacturing expansion involving the installation, transfer, commissioning, validation, and optimization of manufacturing and packaging equipment. This role will provide hands‑on support for both new and existing production assets, with a strong focus on equipment validation, process improvements, troubleshooting, and continuous improvement initiatives within a regulated manufacturing environment.

The ideal candidate will have experience with Allen Bradley PLCs, Cognex Vision Systems, equipment validation activities, and automated manufacturing equipment.

• Lead and execute FAT, IQ, OQ, and PQ validation activities for new, upgraded, and existing equipment.
• Develop validation protocols, reports, and supporting documentation.
• Support equipment commissioning, startup, and installation activities.
• Create installation plans, test challenges, and validation strategies for new equipment.
• Assist with manufacturing line transfers and equipment startup projects.

• Provide day‑to‑day engineering support for automated and manual manufacturing processes.
• Troubleshoot manufacturing equipment and implement corrective actions.
• Support production operations to ensure quality and schedule requirements are met.
• Monitor and improve equipment performance and reliability.
• Drive Overall Equipment Effectiveness (OEE) initiatives.
• Lead process improvement projects and implement operational efficiencies.
• Perform Design of Experiments (DOE) studies using statistical tools such as Minitab.
• Recommend and implement equipment and process improvements based on data analysis.

• Conduct root cause investigations utilizing methodologies such as 5 Whys and 6M analysis.
• Lead CAPA and NCR investigations and documentation.
• Support change control activities within a regulated manufacturing environment.
• Ensure compliance with quality system and validation requirements.

• Partner with Manufacturing, Quality, Maintenance, Safety, Planning, and Validation teams.
• Support new process development and product quality initiatives.
• Participate in cross-functional projects related to manufacturing expansion and equipment integration.

Bachelor's Degree in:

• Mechanical Engineering
• Electrical Engineering
• Mechatronics Engineering
• Electromechanical Engineering

• 3-5 years of manufacturing engineering experience.
• Experience supporting manufacturing equipment in a regulated environment.
• Experience with equipment validation and process qualification activities.

• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Process validation lifecycle experience from process characterization through PQ execution
• FAT, IQ, OQ, and PQ protocol development and execution

• Allen Bradley PLC programming and troubleshooting experience (required)
• Experience commissioning and supporting automated manufacturing equipment

• Cognex Vision Inspection System experience (required)

• Design of Experiments (DOE)
• Root cause investigations
• OEE improvement initiatives
• CAPA and NCR support

• Equipment troubleshooting and production support
• Equipment installation and startup activities
• Corrective and preventative action implementation

• Medical device manufacturing experience preferred
• Regulated manufacturing experience required
• Packaging equipment experience preferred