Summary of Primary Responsibilities:
Responsible for the design, development, validation and implementation of optimized packaging materials, packaging equipment and systems. Interface with all departments to ensure materials and processes are compatible for technology transfer and consistent with established project plans and corporate goals.
- Collaborate with packaging material vendors to evaluate and select cost effective primary, secondary and tertiary packaging materials that meet industry standards for sterile barrier packaging systems (if required).
- Identifies opportunities for cost reduction or process efficiency improvements through standardization and automation.
- Manage capital projects including design, purchase, validation and implementation of equipment and packaging processes according to approved project and change control plans.
- Generates project plans including cost estimation for capital equipment, materials, and testing. Develops and manages projects consistent with department and corporate goals.
- In collaboration in with Research and Development, 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.
Works on problems of technical scope requiring critical thinking and interaction with internal and external technical professionals. Exercises broad judgment within generally defined practices and policies.
No direct reports, however, must be able to participate in multi-disciplined project teams and manage vendors, contractors and consultants as required.
Experience, Knowledge, and Skills Required:
- Requires a BS/MS degree in Packaging Technology, Chemical Engineering, Mechanical Engineering or related scientific field with 5+ years’ experience with packaging processes in a cGMP regulated environment
- Requires material, equipment, and process validation experience according to pharmaceutical and medical device industry standards for sterile barrier packaging systems (ISO, ASTM, etc.).
- Requires experience with medical device or pharmaceutical packaging equipment, automation and processes. Experience with inspection, labeling, assembly, heat sealing, cartoning, and on-line barcode and serialization printing.
- Excellent verbal and written communication skills.
- Excellent equipment and process troubleshooting skills
- Proficient in the use of Microsoft Office suite including Word, Excel, PowerPoint Project and Outlook.
- Demonstrated project management experience with strong presentation skills.
- Ability to manage multiple projects and priorities.
Desired Experience, Knowledge, and Skills:
- Ability to exercise independent judgment in methods, techniques and evaluation criteria for obtaining results
- Knowledge of regulatory compliance requirements
- Familiarity with Lean Manufacturing/Six Sigma
- Working knowledge of Design of Experiments, statistical data analysis and modeling
- Understanding of Quality Systems requirements.
- Familiarity with AutoCAD and Solid works