Principal Packaging & Device Assembly Engineer

Principal Packaging & Device Assembly Engineer

WHO?

INCOG Biopharma Services in Indianapolis, IN is looking for a Principal Packaging & Device Assembly Engineer who will be working closely within the TSMS (Technical Services & Manufacturing Sciences) team. This individual will be responsible for providing strategic leadership for device assembly and packaging development across all facets of Tech transfer, Process Validation, GMP Floor Support, and Continued Process Verification. This role offers the opportunity to work at INCOG’s state-of-art CDMO during an exciting time of growth, contributing towards a better path to market for life-saving drugs.

WHAT?

This is a crucial role within the TSMS team, and the successful individual will be 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 with expert pharmaceutical packaging and combination product development knowledge. Establish 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 with significant business impact
• Lead and develop Senior & Entry Level engineers while establishing comprehensive technical training programs for device assembly and packaging excellence

YOU!

Ideally, candidates will have a Bachelor’s and Master’s degree in Science, Engineering, or Packaging Technology, along with 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 experience (with strong understanding of CDMO operations)

WHY INCOG?

• Paid time off, based on tenure
• 11 paid holidays
• 401(k) plan with company match up, vested immediately
• Choice of health & wellness plans
• FSA and HSA options
• Onsite wellness facility
• Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

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.