Sr. Packaging Engineer, Packaging Transfer - TS

Transfer products (Generic commercialization, Site Transfers, Buy-ins, Third Party & key lifecycle (Alt. API) from R&D or partners to Operations, including supporting packaging development and registration, site transfers, start-up of commercial production, and transfer to lifecycle support.  Minimize obstacles during packaging development, transfer, and commercialization through utilization of risk-mitigation strategies and best practice sharing.

 

Responsibilities

1. Collaborate with and influence development partners/customers during the packaging development and registration of site transfers and new product NDAs and ANDAs, ensuring that all project timelines are met.   

• Represent Packaging Engineering and Quality in the development and filing of new products.

• Collaborate with development partners (e.g. Product Development) during development and pilot scale batch production.

• Collaborate with Purchasing to source new packaging components, if needed.

• Interact with outside vendors to design new packaging components.

• Develop packaging material specifications for new packaging components.

• Provide independent critical review of new products / packaging regarding fit with operational capabilities (e.g. ability of components to run on a particular line, etc.) for processes of all complexity levels, informing functional management and other Packaging Engineers (best practice sharing) about challenging packaging processes (e.g. powder filling, nasal sprays, cold chain), or processes with approaches rarely used at West-Ward (such as controlled atmosphere such as low relative humidity, glass vials, patches).  Particularly challenging packaging may require consultation with senior Packaging Engineers or functional management to collaboratively develop solutions (i.e. titration packs, spoons).  Experience with ointments, creams or product with tube packaging especially desirable 

• Provide feedback to product development or partners on potential critical mismatches between new products/packaging designs and operational capabilities, identify potential non-critical packaging optimization opportunities, and identify operational best practices that may influence packaging design parameters.

• Influence product development or partners in the selection and/or design of packaging which meet product and regulatory requirements, and is compatible with our packaging practices, while meeting marketing and financial needs.

• Create documentation (e.g. SAP Master Data, non-commercial component specifications, non-commercial Master Packaging Specification) based on process design parameters (e.g. formulation and requirements of the product) mutually agreed upon with product development or partners.

• Influence product development or partners to drive shared business ownership and continuous process improvements, particularly in regards to packaging performance (Zero Defects, RFT, Physical Yield, etc.).

• Execute assigned project deliverables with occasional consultation with functional management and/or senior Packaging Engineers for highly complex challenges; can execute most project deliverables independently, but may require consultation on technical aspects for packaging projects of high complexity outside of previous experience.

• Drive highly effective Risk Assessment processes at applicable development and launch gates, in collaboration with product development or partners; identify and escalate critical risk areas, and propose remediation plans to address them.

• Drive mitigation of risks as identified in Risk Assessment, in collaboration with product development or partners (may require influence of product development or partners to mitigate risks still under development control).

• Liaise with Drug Regulatory Affairs (DRA) to support documentation required for product filing or deficiency responses; prepare packaging documentation for submission per Corporate Guidelines. 

• Liaise with Change Management to support packaging changes with impact assessment on finished dosage forms.

• Meet cGMP, FDA, DEA, OSHA and other applicable regulatory and company guidelines.

 

2. Manage Packaging Risk Analysis and Line Trials for new products (Generic, Site Transfers, Buy-ins, and Third Party) as the Quality team representative, and collaborate with development and Hikma partners to ensure that new products meet requirements for quality, cost and manufacturability. 

• Drive highly effective Risk Assessment processes at applicable development and launch gates, in collaboration with development and Operations partners; identify and escalate critical risk areas, and propose remediation plans to address them.

• Drive mitigation of risks as identified in Risk Assessment, in collaboration with development and Operations partner