Job Details

Position summary:

• This engineering role is to be the primary subject matter expert on our vaccine packaging operations.

Position responsibilities:

• This role will be the primary subject matter expert for vaccine packaging operations within Logistics.
• Provides technical support and guidance to ensure packaging systems comply with all relevant governmental regulations and meet internal and external customer and quality needs.
• Partner with outside vendors and internal cross functional teams to develop and engineer packages to ensure functionality, compliance, cost, and timing objectives are met.
• Communicate and participate in packaging material investigations, deviations, troubleshooting, corrective actions, and vendor capability assessments.
• Develop, coordinate, and execute appropriate package qualification/compliance testing as required (shock and vibration, packaging line trials, USP/EP/JP compendia, child resistance CPSC, hazmat, etc.).
• Develop, author, and approve packaging specifications, pallet patterns, and bills of materials for package container/closure systems, secondary, and tertiary packaging.
• Participate in test method validation for packaging materials.

Education & experience:

• Minimum 5 years of experience directly in Pharmaceutical Packaging Operations Support with focus primarily on sterile product primary and secondary packaging material testing and qualification.
• Bachelor of Science in Package Engineering or related Engineering discipline.
• Minimum 5 years of experience directly with package material qualification and or test method validation.

Technical skills required:

• Familiarity with EP and JP compendia testing requirements.
• Understanding of Good Manufacturing Practices.
• Understanding of Method 1 - DMAIC, Six Sigma, or related Statistical Process Control methodology for problem solving.
• Familiarity with USP General Tests and Assay requirements and FDA Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics.
• Familiarity with Design Controls for Medical Device and Combination Products.
• Familiarity with a variety of package performance testing equipment and methods such as (ASTM, ISTA, HDA, Instron, PTI Leak Detection systems, Shock and Vibration Testing).
• Experience with package labeling requirements with specific regard to serialization, trade dress alignment, Batch variable imprinting methods and their impact on operations.
• All contracted resources working onsite under this agreement must adhere to Worker Policy and Procedure.

Top Skills Required:

• Material Science Knowledge MANDATORY! (not just the equipment knowledge but need to know the material science piece)
• Medical Device experience nice to have! (Specification management, writing of bills management, etc)
• Test Methods/validations/qualified material
• TEST METHODS: ASTM studies, USP studies,
• Qualification Packaging Experience (vile, primary or secondary: bottles, tubes, boxes- runs study + test diff packaging parameters)...
• Pharma Package Engineer Exp IDEAL
• Writing package quality protocols/ report writing/lab reports
• At least a few years experience in Pharma (Example: if candidate has 4-6 yrs exp and 2 yrs is in Pharma, that is acceptable)
• (medical device, combination product experience in package design in medical devices -- this would be considerable for role as well)