About this role
Associate Director leading capital projects in a vaccine/biologics manufacturing environment, driving design, qualification, and technology transfer from concept through commissioning and startup.
Key Responsibilities
- Guide design efforts; collaborate with IPTs and vendors; ensure viability of technology; support global network; lead engineering design reviews
Technical Overview
Deep experience in process engineering for biologics/vaccines, hygienic design, P&ID development, stage gate capital management, and C&Q execution; strong cross-functional leadership across IPTs and vendors.
Ideal Candidate
The ideal candidate is a senior engineering leader with 15+ years in pharma/biotech process engineering, specializing in vaccine/biologics manufacturing, hygienic design, and capital project management across stage-gate processes.
Must-Have Skills
At least 15 years of experience in Pharmaceutical/Biotech industry in engineering or manufacturing.10+ years engineering or operations experience related to vaccines or biologicsExperience with an equipment life cycle approach including specificationselectiontesting & commissioningtroubleshooting and qualification.Understanding of hygienic design and unit operations specific to vaccine/biologic manufacturing and aseptic processingExperience with capital projects that followed a stage gate capital management processExcellent collaboration and engagement as a team playerAnalytical and problem-solving skills; ability to lead teamsProject/time management skills; on-timequality deliverablesCore knowledge: unit operationsP&IDHazard Analysisequipment operationcommissioning & qualificationFamiliar with chemical handlingbiosafetycontainment approaches
Nice-to-Have Skills
Experience with vaccines or sterile pharmaceutical environmentTPS (Toyota Production System) understandingMS-ExcelMinitabPowerBILean manufacturing concepts
Tools & Platforms
HPAC/QC toolsP&ID design tools
Required Skills
Process EngineeringChemical EngineeringCapital Project ManagementP&IDHazard AnalysisC&QHygienic designVaccine/biologic manufacturing
Hard Skills
Process EngineeringChemical EngineeringCapital Project ManagementEngineering DesignP&ID developmentHazard AnalysisEquipment selectionVendor interactionFactory Acceptance Testing (FATs)Technology transferCommissioning & Qualification (C&Q)Regulatory ComplianceHygienic designBroad collaborationProject management
Soft Skills
CommunicationInterpersonal relationshipsLeadershipTeamworkProblem solving
Keywords for Your Resume
b.s. degree in engineeringpharmaceutical manufacturingcapital projectsstage gate capital managementhygienic designvaccine manufacturingbiologicsc&qfATsp&idhazard analysisequipment qualificationprocess designproject managementvendor managementtechnical leadershipleadershipcollaborationstage gatec&Qfatsteam leadership
Deal Breakers
BS in Chemical or Mechanical Engineering or related field, 15+ years in pharmaceutical/biotech engineering, Experience with vaccines/biologics manufacturing
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