Senior Packaging & Device Assembly Engineer

Senior Packaging & Device Assembly EngineerWHO?INCOG are looking for a Senior Device Assembly and Packaging Engineer to join their team as they expand their functionality to include combination devices (autoinjectors). This is such a great chance to join INCOG, and you'd be joining them at an integral time of growth- you would have a true impact on delivering life-saving drugs to patients.This exciting opportunity is offered by INCOG Biopharmaceutical Services, who are continuing to build their state of the art sterile injectable CDMO. Having won the Best Places to Work in Indiana 4 years in a row, INCOG is the perfect place to continue building your career!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.The role responsibilities are, but are not limited to: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 commercializationLead 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 impactServe 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 productsLead 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 actionsServes 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 operationsOversee and approve the most complex GMP manufacturing documentation including Master Batch Records, Bill of Materials and Processing Forms for strategic programs with significant business impactLead and develop Senior and Entry Level engineers while establishing comprehensive technical training programs for device assembly and packaging excellenceSupport business development activities and represent INCOG's device assembly and packaging capabilities to prospective clientsYOU!Ideally, candidates will have a Bachelor's and Master's degree in Science, Engineering, or Packaging Technology, along with 4-8 years of experience in pharmaceutical packaging or combination product development and commercialization.Expert experience in global product launches and the associated CMC regulatory requirementsAt least 4 years of GMP experienceExtensive 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 interactionsExperience leading teams and developing technical staff capabilitiesCurious? Send us your resume at apply@leadcandidate.com or you can find more information on our website.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.