Great client is looking for a 12-18 months contract for a Packaging Engineer. This candidate is to be the primary subject matter expert for vaccine packaging operations. Looking for someone with package labeling requirements with specific regard to serialization, trade dress alignment, batch variable imprinting methods and their impact on operations. Should have 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).
location: NEW YORK, New York
job type: Contract
salary: $70 - 80 per hour
work hours: 8am to 4pm
This engineering role is to be the primary subject matter expert on our vaccine packaging operations.
- 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.
- 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.
- Communicate and participate in packaging material investigations, deviations, troubleshooting, corrective actions, and vendor capability assessments.
- Participate in test method validation for packaging materials.
*The role will be primarily on 1st shift and there will be a need for frequent overtime and off shift support to a 24x7x365 operation. This role will be the primary subject matter expert for vaccine packaging operations within Logistics.
EDUCATION & EXPERIENCE:
- Bachelor of Science in Package Engineering or related Engineering discipline.
- 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.
- Minimum 5 years of experience directly with package material qualification and or test method validation.
TECHNICAL SKILLS REQUIRED:
- 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.
- Understanding of Method 1 - DMAIC, Six Sigma, or related Statistical Process Control methodology for problem solving.
- 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).
- Understanding of Good Manufacturing Practices.
- Experience with package labeling requirements with specific regard to serialization, trade dress alignment, Batch variable imprinting methods and their impact on operations.
- Familiarity with EP and JP compendia testing requirements.
- All contracted resources working onsite under this agreement must adhere to the Contingent Worker Policy and Procedure.
- Experience level: Experienced
- Minimum 5 years of experience
- Education: Bachelors (required)
- Design Controls
- Experience with FDA Guidelines
- Statistical Process Control
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.