Sr Manufacturing Engineer

Planet Pharma

North Haven (CT)

On-site

USD 95,000 - 125,000

Full time

29 hours ago

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Job summary

Planet Pharma in North Haven, CT is seeking a Manufacturing Engineer II (12‑Month Contract) to support a major expansion. The role focuses on equipment validation, commissioning, troubleshooting, and continuous improvement of automated manufacturing and packaging lines onsite.

The ideal candidate has experience with Allen Bradley PLCs, Cognex Vision Systems, and DOE studies, with a strong background in regulated manufacturing environments.

Qualifications

Bachelor's degree in a relevant engineering discipline.
3–5 years of manufacturing engineering experience in a regulated environment.
Experience with equipment validation and process qualification activities.
Strong troubleshooting and cross-functional collaboration skills.

Responsibilities

Lead FAT, IQ, OQ, and PQ validation for new and existing equipment.
Develop validation protocols and reports; support installation and commissioning.
Perform day‑to‑day manufacturing support and equipment troubleshooting.
Drive OEE initiatives and process improvements using data analysis.
Lead CAPA and NCR investigations as part of quality and compliance.

Skills

Troubleshooting

Process improvement

DOE

OEE improvements

Root cause analysis

Education

Mechanical Engineering

Electrical Engineering

Mechatronics Engineering

Electromechanical Engineering

Tools

Allen Bradley PLC

Cognex Vision System

Minitab

Job description

Manufacturing Engineer II (Validation & Controls)

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

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.
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
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

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)
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)
Change control processes

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 are transferred into a newly constructed manufacturing area.

Primary responsibilities will include: