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Lead Candidate · 1 week ago

Principal Packaging & Device Assembly Engineer

Fishers, IN

Full-time

Onsite

Senior Level, Lead/Staff

6+ years exp

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 role involves providing strategic leadership for device assembly and packaging development across all facets of Tech transfer, Process Validation, GMP Floor Support, and Continued Process Verification.

EmploymentHuman ResourcesRecruitingStaffing Agency

Hiring Manager

Megan Peacock

Responsibilities

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

Qualification

Pharmaceutical packagingCombination product developmentTechnical transfer leadershipGMP experienceRegulatory requirementsTechnical trainingProject management

Required

Bachelor's and Master's degree in Science, Engineering, or Packaging Technology

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)