Sr Manufacturing Engineer

Manufacturing Engineer II (Validation & Controls)

Location: North Haven, CT

Duration: 12-Month Contract

Schedule: Full-Time, 40 Hours/Week

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

Compensation: Competitive Bid

Position Overview

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.

Key Responsibilities

Equipment Validation & Commissioning

• 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.

Manufacturing Support

• 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.

Continuous Improvement

• 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.

Quality & Compliance

• 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.

Cross-Functional Collaboration

• 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.

Required Qualifications

Education

Bachelor's Degree in:

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

Experience

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

Required Technical Skills

Validation

• Installation Qualification (IQ)
• 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

Controls & Automation

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

Vision Systems

• Cognex Vision Inspection System experience (required)

Process Improvement

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

Manufacturing Engineering

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

Preferred Qualifications

Industry Experience

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

Regulatory & Quality Systems Knowledge

• FDA 21 CFR Part 820
• EU MDR 2017/745
• ISO 13485
• ISO 14971
• IEC 60601

Additional Preferred Skills

• Computer System Validation (CSV)
• SOP development
• Change control processes
• Custom equipment validation
• Microsoft Office Suite proficiency

Project Overview

This role supports a major manufacturing expansion and equipment relocation initiative. Engineers will be responsible for validating, commissioning, troubleshooting, and improving manufacturing and packaging equipment as new assets are installed and existing equipment is transferred into a newly constructed manufacturing area.

Primary responsibilities will include:

• Equipment installation and commissioning
• IQ/OQ/PQ validation activities
• Day-to-day manufacturing support
• Root cause investigations
• CAPA implementation
• OEE initiatives
• Process improvements
• Packaging equipment support
• Automated manufacturing equipment troubleshooting

Ideal Candidate

• 3+ years of manufacturing engineering experience
• Strong Allen Bradley PLC programming background
• Cognex Vision System experience
• Hands-on IQ/OQ/PQ validation expertise
• Experience with automated manufacturing equipment
• DOE and Minitab experience
• Strong troubleshooting and root cause analysis skills
• Comfortable working onsite in a fast-paced manufacturing environment
• Strong cross-functional communication and collaboration skills