What are the responsibilities and job description for the Senior Packaging Engineer position at Adare Pharma Solutions Recruiting Team?
JOB SUMMARY
The Packaging Engineer will support and collaborate with Adare’s Manufacturing Operations team in executing project plans directly related to packaging. This includes new client product introductions, new market launches, supplier changes, manufacturing line support and package development. The Engineer will establish packaging systems that meet the needs of Adare’s customers with optimal process and cost effectiveness. The Packaging Engineer is expected to manage projects and provide expert leadership concerning packaging and packaging systems, and Engineer will collaborate with internal teams such as Quality, Technical Services, and Manufacturing, as well as with Adare’s external customers in reviewing projects, providing input on packaging proposals, and recommending creative packaging solutions.
RESPONSIBILITIES AND LEARNING OPPORTUNITIES
- Evaluate, recommend, develop and implement packaging materials/systems based on multiple factors and influence (i.e. operations, regulatory, marketing, quality, artwork, etc.)
- Perform and/or coordinate material and packaging system testing as required by regulatory filing requirements
- Develop and execute test protocols and reports
- Collaborate with external customers and internal manufacturing sites on packaging development
- Lead or participate on project teams
- Support packaging component and/or equipment selection and validation
- Problem solve quality deviations that occur during manufacturing operations
- Participate in Factory Acceptance Testing (FAT) and/or due diligence testing and investigations.
- Collaborate with key stakeholders to provide technical assessments and support for key component changes
- Partner with Global Procurement to execute on aligned strategy, from vendor identification to implementation
- Develop and sustain a harmonized approach to packaging design
- Manage scale up of new products, manufacturing feasibility batches, writing batch records and summarizing results
- Determine appropriate use of packaging materials and processes to ensure acceptable product stability is obtained for all packaging operations.
- Develop and execute studies for process, equipment, cleaning, facility, computer, and utility validation activities related to bulk drug delivery and finished dosage formulations developed by Research and Development (R&D) and products currently in commercial production, customer and Food and Drug Administration (FDA) requirements.
- Update, review, and approve Standard Operating Procedures (SOPs) and other official documents and determine if validation or re-validation is needed prior to approval of new or changed procedures. Recommend new procedures or revisions were applicable.
- Collaborate with validation projects within the facility including execution of protocols and report writing.
- Technical expertise in the operation of pharmaceutical equipment including but not limited to tablet presses, blenders, fluid beds, roller compactors, pan coaters, mixers, ovens, capsule fillers, packaging equipment and other pharmaceutical equipment.
- Support engineering department with capital projects or trouble shooting of equipment and processes within the facility.
- Contributor of lean manufacturing and continuous improvement programs within the facility
REQUIRED SKILLS AND QUALIFICATIONS
- Bachelors’ degree in Engineering or related technical field and 6 years' experience in Packaging Engineering in a GMP industry
- Packaging development related to: glass, plastics, delivery systems, sterilized components Project management capabilities
- Lean manufacturing skills
- General knowledge of solid oral dose processing is a plus
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