Packaging Engineer

Primary Container – Technical Launch Integrator

Key Responsibilities:

· Lead different global and local project teams and act as a core team member in the value chain team.

· Provide regular updates to senior leaders, partners, and sponsors through comprehensive reports, presentations, and ad-hoc communications

· Handle all technical outputs for file submission and launch readiness, on time and with the right quality.

· Provide up to 1 year of post-launch support to ensure manufacturing stabilization and fluent transfer of ownership.

· Work with the Drug Delivery System development team (DDS) to optimize the design of primary container for commercial assembly, packaging, and distribution.

· Collaborate with the MSAT Packaging Center of Excellence team to design, implement, and validate commercial secondary and tertiary packaging components, with an emphasis on sustainability considerations and patient requirements

· Together with internal partners and suppliers, search for optimal off-the-shelf and custom designed secondary packaging materials solutions.

· Drive development, implementation, and validation of the packaging processes at commercial scale and according to outstanding examples and standard procedures.

· Partner with Project Engineers to ensure that equipment is accurately designed, tested, installed, and qualified.

· Deliver a robust tech transfer documentation set in line with applicable packaging design transfer procedures; includes a design transfer plan and report, control strategy, FMEA, equipment qualification and process validation, distribution testing, procedures, protocols, ad-hoc test protocols, data analysis, and summary reports.

· Responsible for the consolidation of budget plans for New Product Introduction (NPI), ensuring alignment with strategic objectives and financial targets

Qualifications:

Education:

· Minimum of a Bachelor's/University or equivalent degree is required; advanced degree or focused degree in Engineering or Science preferred

Experience and Skills:

Required:

· Minimum 7+ years of relevant work experience in the pharmaceutical development or manufacturing area.

· Prior design and validation experience with primary packaging of oral solids

· Experience in leading large and complex projects from initiation to completion with a multifunctional team in a global context

· Demonstrated ability to operate with minimal guidance, requiring only strategic direction to self-direct, plan, and execute projects effectively. Proactively anticipates needs and potential issues, escalating matters as appropriate to ensure timely resolution

· Proven experience in Packaging Operations, Engineering, Project Leadership, and/or R&D

· Demonstrated experience in Technical Launch Management, Product Technical Transfer, New Product Introduction, and/or New Product Launch

· Strong communication and an authentic personal leadership style, with ability to successfully drive, contribute, and influence in different virtual teams

· Proven leadership in stakeholder management, which involves effectively engaging with diverse stakeholders and managing upwards to build strong relationships with senior leaders.

· Demonstrated experience in one or more of the following areas: Change Control, Risk Management, Qualification and Validation

· Experience MS Project or equivalent applications

· Experience in Synthetic pharmaceutical development or pharmaceutical manufacturing

Other:

· Location: US (strongly preferred in greater Philadelphia area for onsite collaboration, when required)

· Requires proficiency in English (oral and written)

· May require up to 10% of domestic and/or international travel

Project 1

Support registration batches production

Secondary and tertiary pkg development and implementation

Product filing/launch

Project 2

Support registration batches production

Support primary packaging design

Project 3

Early development