Dr. Reddy's Laboratories · 1 week ago

Packaging Engineer

Princeton, NJ

Full-time

Hybrid

Mid Level

2+ years exp

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Responsibilities

Provide necessary support to External Manufacturing production at various CMO sites for Rx, OTC, and nutraceutical products.

Qualification of primary and secondary/tertiary packaging systems.

Execute testing to support development and submission activities.

Provide critical inputs for product stability and regulatory submissions.

Author, review, and coordinate approvals for documentation.

Provide packaging structural engineering, development, and design support.

Coordinate structural and artwork development process for new SKU development.

Initiate and execute primary and secondary package design projects.

Maintain packaging database and documentation.

Initiate change control for packaging related changes at CMO.

Manage projects related to new product launch packaging activities.

Manage suppliers and co-packers, provide packaging oversight, and troubleshoot as necessary.

Domestic travel may be required up to 20%.

Qualification

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Regulated industry experiencePackaging variety experienceDevice experienceSerialization experienceCGMP knowledgeFDA guidelines knowledgeQuality Systems knowledgePPPA/CPSIA regulations knowledgeISO standards knowledgeUSP standards knowledgeISTA standards knowledgeASTM standards knowledgePackaging operations experienceTechnical writing skillsProblem-solvingTeamworkCommunicationTime managementPackaging OperationsISO StandardsUSP StandardsISTA StandardsASTM Standards

Required

BS degree in Engineering (Packaging preferred, Mechanical, Materials Science)

2-6 years of experience in regulated industry (pharmaceutical or consumer products packaging with Rx packaging preferred)

Experience with a variety of packaging on both primary (bottles, closures, blisters, pouches) and secondary/tertiary packaging (cartons, labels, shippers, displays). Device or combination product experience and Serialization experience a plus

Experience with cGMP's, all applicable FDA guidelines and Quality Systems. Experience with PPPA/CPSIA regulations and compliance. Prefer additional understanding of ISO, USP, ISTA, ASTM standards

Experience with PPPA (Poison Prevention Packaging Act), CPSIA (Consumer Product Safety Improvement Act) regulations and compliance

Additional understanding of ISO (International Organization for Standardization), USP, ISTA (International Safe Transit Association), ASTM (American Society for Testing and Materials) standards preferred

Experience in packaging operations desired

Comfortable working in a team environment with tight deadlines

Excellent communication, technical writing, and presentation skills