Lead Candidate · 2 weeks ago
Principal Packaging & Device Assembly Engineer
Fishers, IN
Full-time
Onsite
Senior Level, Lead/Staff
6+ years expINCOG Biopharmaceutical Services is expanding their functionality to include combination devices, and they are seeking a Principal Device Assembly and Packaging Engineer to join their team. This role involves driving strategic delivery of technical guidance and leadership in complex packaging and device assembly processes, impacting the delivery of life-saving drugs to patients.
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
Serve as company expert in combination devices (auto injectors), 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
Serves as lead TSMS representative in strategic project teams and leads enterprise communications with key customers. Recognized as Expert Subject Matter Expert for device assembly and packaging processes across all facility operations
Oversee and approve the most 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 while 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
Qualification
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)
Excellent presentation and communication skills for executive-level and client interactions
Experience leading teams and developing technical staff capabilities
Company
Lead Candidate
Lead Candidate is a recruiting company that provides staffing, talent management, and HR solutions for the pharma sector.
Founded in 2021Newcastle Upon Tyne, Newcastle upon Tyne, GBR
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Fiona Cruickshank
Founder and Director
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