Hiring PACKAGE ENGINEER in Kalamazoo,MI @Direct Client,

Company: Infobahn Softworld Inc.
Location: Kalamazoo
Posted on: November 19, 2020

Job Description:

-- SENIOR PACKAGE ENGINEER -- POSITION SUMMARY This engineering role is to be the primary subject matter expert on our vaccine packaging operations. POSITION RESPONSIBILITIES 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 timinfg objectives are met. Develop, coordinate, and execute appropriate package qualificationcompliance testing as required (shock and vibration, packaging line trials, USPEPJP compendia, child resistance CPSC, hazmat, etc.). Develop, author, and approve packaging specifications, pallet patterns, and bills of materials for package containerclosure 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 Client's Contingent Worker Policy and Procedure. NOTES - TOP SKILLS 1. Qualification Packaging Experience (vile, primary or secondary bottles, tubes, boxes- runs study + test diff packaging parameters)... 2. TEST METHODS ASTM studies, USP studies, - Pharma Package Engineer Exp IDEAL if don't have test methods, then need package qual. exp in Pharma (1 Pharma Package Engineer exp) (2 Test Methodsvalidationsqualified material) (3 Experience writing package quality protocols report writinglab reports) - Medical Device experience nice to have! (Specification management, writing of bills management, etc) - 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) - Bachelors Degree REQUIRED! (Prefer degree in Package Engineering) - Material Science Knowledge MANDATORY! (not just the equipment knowledge but need to know the material science piece) (medical device, combination product experience in package design in medical devices -- this would be considerable for role as well)SDL2017

Keywords: Infobahn Softworld Inc., Kalamazoo , Hiring PACKAGE ENGINEER in Kalamazoo,MI @Direct Client,, Engineering , Kalamazoo, Michigan