Senior Packaging Engineer

Adare Pharma Solutions•Philadelphia, PA

1d•Onsite

About The Position

Adare Pharma Solutions is a global Contract Development and Manufacturing Organization (CDMO) with locations across North America and Italy. We offer a wide range of manufacturing, packaging, and research and development services. Our clients range from growing biotech firms advancing groundbreaking clinical trials to established pharmaceutical companies producing high volumes of approved, widely used medicines. By combining top talent from the life sciences industry with modern research and manufacturing technologies, Adare enables clients to deliver potentially lifesaving medicines in more easily consumable formats - particularly for patients such as infants or the elderly. This is the meaning behind “Transforming Drug Delivery – Transforming Lives.” When it comes to being an employee of Adare, although we are located across multiple countries and come from diverse backgrounds, we work together toward a common purpose. Supported by leadership that is experienced and highly regarded in the industry, we are paving the way for a brighter and better future by attracting top talent from both within and beyond the CDMO space. In addition to delivering high-quality results for our external clients, we foster a collaborative, client-centric culture internally - one where employees support one another, share knowledge, and encourage each other to bring their best selves to work each day. Adare is Private Equity owned and poised for growth. Employees are provided with internal development opportunities to progress within the organization, enhancing their professional skills and industry knowledge through Adare’s investment in their growth. We offer a variety of fields to embark in, including manufacturing, engineering, quality, chemistry, formulations, analytical research and development, finance, supply chain, sales, marketing, project management, human resources, and environmental health and safety.

Requirements

Bachelors’ degree in Engineering or related technical field
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

Nice To Haves

General knowledge of solid oral dose processing is a plus

Responsibilities

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