Principal Packaging & Device Assembly Engineer

Principal Packaging & Device Assembly Engineer

INCOG is seeking a Principal Device Assembly and Packaging Engineer to join their team as they expand their offerings to include combination devices (autoinjectors). This role presents a unique opportunity to join INCOG during a pivotal growth phase and to have a direct impact on delivering life‑saving drugs to patients.

This opportunity is offered by INCOG Biopharmaceutical Services, which is building a state‑of‑the‑art sterile injectable CDMO. INCOG has been named one of the Best Places to Work in Indiana for four consecutive years.

This is a crucial role within the TSMS team, responsible for driving strategic delivery of technical guidance and leadership throughout the most complex packaging and device assembly processes.

• As the company expert in combination devices (autoinjectors), own the strategic execution of complex packaging/device assembly development activities in cross‑functional teams, establishing strategic development of primary, secondary, and tertiary packaging while managing critical due dates and project timelines from clinical to commercialization.
• Lead strategic client team meetings to understand complex packaging requirements and develop comprehensive technical documentation such as strategic Technical Transfer Plans, Process Flow Diagrams (PFD), Gap Assessments, Summary Reports, and Process FMEAs.
• Serve as company expert in combination devices, packaging materials, and manufacturing processes with deep expertise in global packaging standards for pharmaceutical drug products, parenteral container‑closure systems, and combination products.
• Lead enterprise‑wide technical troubleshooting and investigations of critical packaging issues to support strategic root cause analysis, comprehensive product impact assessment, and transformational corrective and preventive actions.
• Act as TSMS representative in strategic project teams and lead enterprise communications with key customers, recognized as an expert subject matter expert for device assembly and packaging processes across all facility operations.
• Oversee and approve complex GMP manufacturing documentation
  , including Master Batch Records, Bill of Materials, and Processing Forms for strategic programs with significant business impact.
• Lead and develop Senior and Entry Level engineers by establishing comprehensive technical training programs for device assembly and packaging excellence.
• Support business development activities and represent INCOG’s device assembly and packaging capabilities to prospective clients.

Ideally, candidates will have a bachelor’s and master’s degree in science, engineering, or packaging technology, and 6‑8 years of experience in pharmaceutical packaging or combination product development and commercialization.

• Expert experience in global product launches and the associated CMC regulatory requirements.
• At least 5 years of GMP experience.
• Extensive experience in technical transfer leadership within the pharmaceutical manufacturing environment, with a strong understanding of CDMO operations.
• Excellent presentation and communication skills for executive‑level and client interactions.
• Experience leading teams and developing technical staff capabilities.

Curious? Send us your resume at  or find more information on our website.

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief, and marriage and civil partnerships.