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Full-time
Posted 46d ago
Apply by Aug 31
~40 hrs/week
Responsibilities
Manage and execute packaging development, validation, and shop floor operations to ensure compliance with regulatory requirements. Oversee artwork approval, material specifications, and the implementation of packaging systems across regulated markets.
Requirements
Requires expertise in primary, secondary, and tertiary packaging configurations and experience with various packing machinery. Must be proficient in cGMP and regulatory standards such as USFDA, EU, and WHO.
Full job description
Job Description Summary
To manage and execute packaging development, validation, and shop floor operations in compliance with regulatory requirements, ensuring robustness, efficiency, and compliance of packaging systems across regulated markets.
Job Description
Key Responsibilities:
1. Artwork Evaluation & Approval:
Review and evaluate packaging artworks for compliance with regulatory and marketing requirements
Coordinate with QA, Regulatory Affairs, and vendors for artwork approval
Ensure correct implementation of printed packaging materials
2. Packaging Development & Change Management:
Design and develop primary, secondary, and tertiary packaging configurations
Manage packaging change parts design, modification, and implementation
Execute feasibility studies and provide technical inputs for new product introduction
Ensure compatibility of packaging with product and machinery
3. Material Approval System (MAS):
Initiate and manage material approval processes
Evaluate vendor samples and ensure compliance to specifications
Support vendor qualification and packaging material standardization
4. Packaging Specifications & Documentation:
Develop and review packaging specifications
Prepare Master Packaging Records (MPR), SOPs, protocols, and reports
Ensure documentation aligns with cGMP and regulatory requirements
5. Shipping Studies & Stability Support:
Design and execute shipping validation studies
Support packaging design for transportation robustness
6. Packaging Validation & Qualification:
Execute packaging validation (PV)
Support equipment qualification (IQ/OQ/PQ)
Ensure compliance with validation requirements
7. MVTR Evaluation:
Conduct and interpret MVTR studies
Evaluate barrier properties of packaging materials
8. Shop Floor Monitoring & Support:
Monitor packaging operations
Provide troubleshooting support
9. Equipment Handling:
Experience in bottle, blister, pouch,sachet and secondary packing machines
Endo combined with Mallinckrodt Pharmaceuticals in 2025 to better serve customers and improve outcomes for the patients we support.
From this union, we established two focused, standalone companies:
– Keenova Therapeutics, a branded therapeutics business
– Par Health, a generics and sterile injectables business
To learn more, follow Keenova and Par Health on LinkedIn and visit keenova.com and parhealth.com.
Endo combined with Mallinckrodt Pharmaceuticals in 2025 to better serve customers and improve outcomes for the patients we support.
From this union, we established two focused, standalone companies:
– Keenova Therapeutics, a branded therapeutics business
– Par Health, a generics and sterile injectables business
To learn more, follow Keenova and Par Health on LinkedIn and visit keenova.com and parhealth.com.