Medical Device Packaging Engineer Project Manager - III

Title: Medical device Packaging Engineer Project Manager - III

Duration: 24 Months

Remote (Domestic Travel: 25%)

Qualifications:

Candidate must have Pharma experience/Packaging syringes, Must have worked on Capital projects, and must have Shop Floor packaging experience. Understand equipment and validation, medical devices.

Requirements:

• Must showcase prior exposures in the areas of Project Management, Device packaging/operation
• Not looking for the upstream side of the device packaging operation, looking for more downstream that this role will handle: provide tech transfer of the product to the CMO and be responsible as a project manager.
• The new packaging line that will be installed in PCI Philly will be the PFS packaging line, so ideally, the candidate needs to understand PFS packaging operations and equipment. 50% of experiences need to have prior PFS expertise.

Responsibilities:

• 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:

A bachelor's degree in Packaging Science/Engineering, Mechanical Engineering, or a related technical discipline (such as Chemical Engineering or Material Engineering) is mandatory.

Required Experience and Skills:

• Minimum of 10 years experience in the medical device or combination product engineering and pharmaceutical field, with extensive practical knowledge in supporting packaging operations, managing packaging materials and components, and overseeing packaging processes
• Strong preference for candidates with leadership experience at a pharmaceutical packaging facility or an External Manufacturing site.
• Extensive experience in handling Capital packaging equipment projects, including technology transfers, designing packaging lines, creating purchase specifications, managing equipment installation and validation, pursuing operational excellence, and troubleshooting on the shop floor.
• Broad experience with devices and combination products, covering design control to product and technology transfer for both new and existing packaging facilities.
• Exceptional project management skills, from conception and initiation through project close-out.
• Thorough knowledge and proven expertise in GMP application and quality systems, particularly in process and equipment qualification, change control, deviation management, and cleaning qualification.
• Expert grasp of relevant scientific or technical concepts to handle routine and complex tasks, along with advanced practical knowledge of techniques applicable to these tasks.
• Experience with key manufacturing change control compliance systems such as Veeva and/or other similar systems
• Extensive experience with quantitative decision tools for risk management and options analysis to support risk-based decision-making.
• Exhibited leadership qualities and inclusive practices in managing a diverse, cross-functional team.
• Familiarity with the regulatory standards of key pharmaceutical markets, such as USFDA cGMPs and EMA guidelines.
• Demonstrate the ability to have a continuous learning mindset and commitment to experiment, learn, and embrace informed risk-taking and doing things in new ways without fear of failure.
• Adopt a critical mindset in decision-making to ensure thorough analysis while considering potential impacts on key stakeholders.
• Ability to serve as a change agent to work collaboratively and act with an enterprise mindset to make appropriate tradeoffs for the project & organization's greater good.
• Strong analytical and decision-making abilities, combined with outstanding oral and written communication skills