About this opportunity
Planet Pharma lists this Sr Manufacturing Engineer opportunity in north haven, Connecticut. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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
Worksite address
north haven, CT, 06473, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.