Packaging Engineer Project Manager - III (Senior)

This role serves as an essential part of the External Manufacturing & Network Equipment team, overseeing product and technology transfers to Contract Manufacturing Organizations (CMOs). The role involves leading technical interactions with external packaging partners, which are Contract Manufacturing Organizations in the ExM space. The incumbent will work closely with other ExM functions (Quality, Operations, Supply Chain, Procurement) and technology experts within the Centers of Excellence. The engineer will leverage their scientific, technical, and business expertise to lead teams in solving complex packaging issues, optimizing processes, and ensuring compliance, focusing on developing and executing primary and secondary packaging components for Small and Large Molecule assets, assembling Medical Device Combination Products, designing packaging equipment, and ensuring packaging process control and efficiency.

Core Responsibilities :

• Tasked with leading and implementing technology transfers, qualifications, validations, process enhancements, and change controls for projects involving Small and Large Molecule and medical devices and combination products.
• Assurance of compliant packaging and assembly process transfer, site readiness and execution excellence.
• Offer technical expertise in quality and supply investigations with external packaging partners. Lead discussions on packaging processes, equipment, and components to help identify root causes and develop effective corrective and preventive actions.
• Collaborate with internal packaging teams on project timelines, development of primary, secondary, and tertiary packaging components, testing methods, packaging processes, serialization requirements, and transport / storage systems for the finished product.
• Collaborating with external packaging partners in weekly meetings to ensure project tasks are executed according to the project schedule.
• Collaborate with external packaging partners to ensure packaging readiness, including component specifications, operation process, risk assessment (FMEA), testing method transfer, and line qualifications (IQ, OQ, PQ) and validation (PPQ).
• Oversees Change Control activities for tech transfer workflows to ensure timely task execution.
• Operating independently while ensuring coordination, communication, and oversight on all technical aspects related to the involved External Packaging partners.

Education Minimum Requirement :

Required Experience and Skills :

Quals

8 yrs of exp - Janet Raguso CSP - Please review the job description very carefully and submit those candidates that are very qualified

Remote 25% travel. Manager would prefer candidate that worked longer assignments not jumping from one assignment to another. Candidate must have Pharma experience / Packaging syringes, Must have worked on Capital projects, Shop Floor packaging experience. Understand equipment and validation, medical devices

Must showcase prior exposures in the areas of Project Management, Device packaging / operation

Not looking for upstream side of the device packaging operation, looking for more downstream that this role that will handle : provide tech transfer of the product to the CMO and responsible as a project manager.

new packaging line that will be installed in PCI Phily will be PFS packaging line so ideally, the candidate needs to have understanding of PFS packaging operations and equipment. 50% of experiences need to have prior PFS expertise.