Packaging Development Engineer

Katalyst CRO; Fort Washington (Montgomery County); On-site; USD 110,000 - 140,000; Full time

Job summary

Katalyst CRO is seeking an experienced Packaging Development Engineer to lead end-to-end packaging development initiatives in highly regulated environments. You will collaborate with R&D and cross-functional teams to ensure cGMP compliance and robust packaging solutions for consumer, OTC, or pharmaceutical products.

The role requires hands-on experience with packaging materials, testing methodologies, and successful line trials.

Qualifications

• Must have 6–8 years in the industry with 3+ years in Package Development.
• Experience in Consumer, OTC, or pharmaceutical industries is mandatory.
• Strong knowledge of packaging materials, equipment, testing, and development processes.
• Hands-on experience in regulated, cGMP-compliant environments.
• Experience leading packaging development projects and coordinating cross-functionally.
• Strong documentation and technical writing skills.
• Knowledge of SAP for packaging/material management activities.

Responsibilities

• Plan and execute packaging engineering assignments for lifecycle initiatives.
• Develop and assess packaging systems (Primary, Secondary, Tertiary).
• Lead packaging design development and project execution.

Skills

Project management

Packaging development

Regulatory compliance

Technical writing

Cross-functional collaboration

cGMP knowledge

Tools

SAP

Job description

Summary

We are seeking an experienced Packaging Development Engineer with strong expertise in packaging engineering, package development, and project management within Consumer, OTC, or Pharmaceutical industries. The ideal candidate will possess hands‑on experience in highly regulated environments with strong knowledge of cGMP practices, packaging materials, testing methodologies, and packaging line trials. The candidate will lead end‑to‑end packaging development initiatives, collaborate with cross‑functional stakeholders, and ensure packaging compliance with government and corporate standards.

Roles & Responsibilities

• Plan and execute packaging engineering assignments related to large lifecycle management initiatives.
• Develop and assess packaging systems involving Primary, Secondary, and Tertiary packaging materials.
• Lead package design development activities and ensure successful execution of packaging projects.
• Create, review, and approve package component specifications and packaging documentation.
• Collaborate closely with R&D teams for component design changes and product‑related updates.
• Prepare and manage packaging development documentation including:
  • Package Component Specifications
  • Packaging Development Assessments & Plans
  • Line Trial Protocols & Reports
  • Package Development Reports
• Coordinate and execute packaging line trials and packaging validation/testing activities.
• Determine and manage physical testing requirements to ensure product/package integrity throughout manufacturing and distribution.
• Troubleshoot packaging‑related manufacturing and field issues and drive resolution activities.
• Ensure all packaging projects comply with cGMP, regulatory, and corporate quality standards.
• Develop copy & graphics specifications, pallet patterns, and finished goods specifications.
• Perform SAP‑related activities including:
  • Data Entry
  • Raw Material Code Requests
  • Bill of Material (BOM) creation and revisions
• Coordinate with stakeholders to track, monitor, and manage package development processes effectively.

Education & Experience

• 6-8 years of industry experience with at least 3+ years in Package Development.
• Experience in Consumer, OTC, or pharmaceutical industries is mandatory.
• Strong knowledge of packaging materials, packaging equipment, testing, and package development processes.
• Hands‑on experience working in highly regulated and cGMP‑compliant environments.
• Experience leading packaging development projects and cross‑functional coordination.
• Strong documentation and technical writing skills.
• Knowledge of SAP for packaging/material management activities.