Position Scope: Leads diverse process improvement and new process development projects. Acts as technical lead in multi-disciplined project teams. Works on problems of diverse scope where analysis of data is utilized to make timely and effective decisions. Performs design, purchase, validation and implementation of equipment and system used in manufacturing and packaging of medical devices and drug products. Specific Tactical Responsibilities: Collaborate with packaging material vendors to evaluate, select and validate cost effective primary, secondary and tertiary packaging materials that meet industry standards for sterile-barrier and non-sterile barrier packaging systems. Identifies opportunities for cost reduction or process efficiency improvements through standardization and automation. Develops and manages projects consistent with department and corporate goals. Tests packaging materials, develops and validates packaging processes to support regulatory approval and introduction of new products to market. Requires interaction with multiple departments internally, external material and equipment vendors and coordination of multidisciplinary tasks. Prepares draft-operating procedures for new equipment and processes and works with Document Control to ensure final processes are implemented through the document mastering process Develops/edits packaging material master part specifications and/or artwork specification to meet requirements Performs process/product risk assessments and prepares reports according to company procedures Prepares equipment (IOQ, PQ) and process validation (PV) protocols Works with the packaging department to perform/coordinate the execution of equipment and process validations according to approved protocols. Job Complexity: Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise. Supervisory Responsibilities: None; must be able to participate in and lead multi-disciplined project teams. Required Qualifications: Bachelor's degree in in Chemical Engineering, Packaging Technology or related field or related experience 5-8 years' experience in a cGMP regulated environment Experience with medical device packaging and labeling equipment and processes Demonstrated experience with material, equipment, and process validation according to medical device and pharmaceutical industry standards Desired Experience, Knowledge, and Skills: Master's Degree in Chemical or Packaging Engineering Previous experience with sterile barrier packaging systems Experience with a heat sealing, cartoning, vision systems and on-line barcode printing and coding Excellent equipment and process troubleshooting skills Effectively manage time and deliver results on time Excellent communication skills, both written and verbal, with the ability to educate colleagues and customers of packaging justification, improvement opportunities, and best practices. This includes being comfortable presenting to large groups and management. Demonstrated excellent follow-through both with daily workload and long-term projects, operating autonomously with minimal guidance. Possess and understanding of workload and be able to self-prioritize. Possess the ability to be actively involved in trouble-shooting packaging and production process concerns by interacting with internal and external teams. Track record of career advancement and increased / diversified knowledge and experiences; demonstrated ambition and learning agility thru stretch roles or assignments. Demonstrated ability to drive for results through passion and commitment while leveraging best practices and risk based approaches to work \"smarter\". Demonstrates humility in the face of complexity. Strong personal values including honesty, integrity, people development, and drive for results. Ability to quickly assess situations and utilize the appropriate response to meet specific needs of the business. Able to remain calm and work well in high pressure situations. Demonstrates initiative to take leadership, ownership and accountability for difficult or complex challenges.Salary Range: NAMinimum Qualification5 - 7 years Associated topics: ceramic, corrosion, glass, medical, metallic, metallurgist, molecular, polymer, polyurethane, welding
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