Packaging Engineer

Katalyst CRO; Manchester (NH); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO is seeking an experienced Packaging Engineer to sustain packaging for existing products and processes, ensuring quality, regulatory compliance, continuity of supply, and cost savings. The role includes supporting new product development through design, development, verification and qualification of packaging systems and manufacturing processes.

Responsibilities include leading packaging projects, ensuring regulatory compliance, testing protocols, Change Control support, and

Qualifications

• Bachelor's degree in Packaging Engineering or related field.
• Minimum 5 years of packaging engineering experience.
• Strong knowledge of packaging materials and manufacturing processes.
• Packaging design and development experience.
• Statistical analysis and DOE proficiency.
• Root Cause Analysis and problem solving.
• Familiarity with Change Control processes.
• Experience managing packaging projects from initiation to implementation.
• Cross-functional collaboration and strong communication.
• Experience in regulated environments (pharma/medical device) and Lean/Continuous Improvement.

Responsibilities

• Lead and execute packaging engineering projects related to quality investigations and CAPA.
• Regulatory compliance and NOC management.
• Cost reduction initiatives and NPI support.
• Manage multiple packaging projects with timelines and milestones.
• Develop testing protocols and support Change Control.
• Collaborate with manufacturing, suppliers, quality, regulatory, and cross-functional teams.
• Evaluate and qualify new packaging materials, components and systems.
• Create packaging material specs, drawings and procedures.
• Identify cost-saving opportunities through new materials and design changes.
• Perform root cause analyses using DMAIC/DOE techniques.
• Support packaging process qualification and implementation at plants.
• Travel to facilities and suppliers as needed.

Skills

Packaging materials

Packaging design

Statistical analysis

Design of Experiments

Root cause analysis

Change control

Project management

Lean / CI

Education

Bachelor's degree in Packaging Engineering

Job description

SummaryWe are seeking an experienced Packaging Engineer to join the Pharmaceutical R&D team. This role focuses on sustaining engineering activities for existing product packaging and packaging processes, supporting quality, regulatory compliance, continuity of supply, and cost-saving initiatives. The engineer will also support new product development by designing, developing, verifying, and qualifying packaging systems and manufacturing processes.

• Lead and execute packaging engineering projects related to:
• Quality investigations and CAPA
• Regulatory compliance
• Supplier Notices of Change (NOC)
• Cost reduction initiatives
• New Product Introductions (NPI)
• Manage multiple packaging projects with moderate complexity while meeting project timelines and milestones.
• Develop testing protocols and support Change Control activities.
• Collaborate with manufacturing sites, suppliers, quality, regulatory, and cross-functional teams to implement packaging changes.
• Evaluate, approve, and qualify new packaging materials, components, and systems.
• Create packaging material specifications, engineering drawings, and packaging procedures.
• Recommend packaging improvements and cost-saving opportunities through new materials and design modifications.
• Troubleshoot packaging-related issues using root cause analysis, statistical methods, DMAIC, and Design of Experiments (DOE).
• Perform financial analysis and project justification for packaging initiatives.
• Support manufacturing plants during packaging process qualification and implementation.
• Travel to manufacturing facilities and packaging suppliers as needed.
• Experience with one or more of the following is highly desirable.
• Flexible and rigid packaging films
• HDPE containers
• Protective packaging
• Thermoforming
• Flow-wrap packaging
• Form/Fill/Seal (FFS)
• Printing technologies
• Packaging validation and qualification

SummaryWe are seeking an experienced Packaging Engineer to join the Pharmaceutical R&D team. This role focuses on sustaining engineering activities for existing product packaging and packaging processes, supporting quality, regulatory compliance, continuity of supply, and cost-saving initiatives. The engineer will also support new product development by designing, developing, verifying, and qualifying packaging systems and manufacturing processes.

Roles & Responsibilities

• Lead and execute packaging engineering projects related to:
• Quality investigations and CAPA
• Regulatory compliance
• Supplier Notices of Change (NOC)
• Cost reduction initiatives
• New Product Introductions (NPI)
• Manage multiple packaging projects with moderate complexity while meeting project timelines and milestones.
• Develop testing protocols and support Change Control activities.
• Collaborate with manufacturing sites, suppliers, quality, regulatory, and cross-functional teams to implement packaging changes.
• Evaluate, approve, and qualify new packaging materials, components, and systems.
• Create packaging material specifications, engineering drawings, and packaging procedures.
• Recommend packaging improvements and cost-saving opportunities through new materials and design modifications.
• Troubleshoot packaging-related issues using root cause analysis, statistical methods, DMAIC, and Design of Experiments (DOE).
• Perform financial analysis and project justification for packaging initiatives.
• Support manufacturing plants during packaging process qualification and implementation.
• Travel to manufacturing facilities and packaging suppliers as needed.
• Experience with one or more of the following is highly desirable.
• Flexible and rigid packaging films
• HDPE containers
• Foil pouches
• Corrugated packaging design
• Protective packaging
• Thermoforming
• Flow-wrap packaging
• Form/Fill/Seal (FFS)
• Printing technologies
• Packaging validation and qualification

Required Qualifications:

• Bachelor's degree in Packaging Engineering or a related Engineering discipline (Mechanical, Chemical, Biomedical, etc.).
• Minimum 5 years of packaging engineering experience.
• Strong knowledge of:
• Packaging materials and manufacturing processes
• Packaging design and development
• Statistical analysis
• Design of Experiments (DOE)
• Root Cause Analysis and problem solving
• Change Control processes
• Experience managing packaging engineering projects from initiation through implementation.
• Strong project management and cross-functional collaboration skills.
• Ability to manage multiple priorities with minimal supervision.
• Experience applying Lean Manufacturing and Continuous Improvement principles.
• Strong written, verbal, and presentation skills.
• Experience in the medical device, pharmaceutical, or healthcare industry.
• Knowledge of GMP-regulated manufacturing environments.
• Experience supporting manufacturing process qualification and packaging validation. Medical device, particularly Orthopaedic industry experience.