Position Details

Salary $142K – $224K USD / year

Type Full-Time

Experience mid

Exp. Years 8+ years

Education Bachelor's degree in business, engineering, pharmaceutical sciences or related field with a minimum of 8 years of relevant experience; Master’s degree with 6 years; or PhD with 4 years

Category Engineering (Non-Software)

About this role

Associate Director, Engineering leads the sterile production expansion and ongoing operations at the Rahway site, focusing on aseptic manufacturing excellence, hiring and capability building, and compliance with cGMP standards.

Key Responsibilities

Build and lead the Operations organization from inception
Partner with engineering, validation, and quality to align operational requirements
Establish GMP-operating procedures and training
Own process readiness for sterile manufacturing
Drive continuous improvement

Technical Overview

Role requires deep expertise in aseptic filling lines, isolators, lyophilizers, and cross-functional execution of C&Q to GMP, with a strong emphasis on Lean/Six Sigma and data-driven management.

Ideal Candidate

The ideal candidate is an experienced engineering leader with a proven track record in aseptic sterile manufacturing, capable of building an operations organization, driving C&Q to cGMP operations, and executing a rapid expansion with a focus on safety, quality, and throughput.

Must-Have Skills

Proven leadership in aseptic drug product manufacturing operationsAseptic filling linesisolatorslyophilizers knowledgeLean/Six Sigma and operational excellencecGMP/ aseptic processing knowledgeCross-functional collaboration and strong communication

Nice-to-Have Skills

Hands-on C&Q experienceEnvironmental monitoring programsExperience with regulatory readiness for aseptic operationsProcess Hazard Analyses and Quality Risk Assessments

Tools & Platforms

Electronic batch recordsSampling plansSOP deployment

Required Skills

AdaptabilityChemical EngineeringCustomer-FocusedData-Driven Decision MakingDrug Product DevelopmentEstimation and PlanningManufacturing Quality ControlPharmaceutical Process DevelopmentProcess Control AutomationProcess OptimizationProduct FormulationSafety ComplianceStrategic ThinkingTechnical MentoringTechnical Writing

Hard Skills

AdaptabilityChemical EngineeringAdaptabilityChemistryProcess Control AutomationProcess OptimizationManufacturing Quality ControlDrug Product DevelopmentEstimation and PlanningSafety ComplianceTechnical MentoringTechnical Writing

Soft Skills

LeadershipProject ManagementStrategic ThinkingInterpersonal RelationshipsCommunication

Industry & Role

Industry Healthcare & Medical

Job Function Lead aseptic production operations and capability development for a new sterile facility expansion.

Clearance & Visa

Visa Sponsorship Yes

Keywords for Your Resume

associate directorengineeringsterile productionaseptic processingfilling lineisolatorslyophilizersgmpcGMPcontamination controldata integrityoperational excellenceleansix sigmavisual factorykpibatch releaseelectronic batch recordsdeviation preventionenvironmental monitoringaseptic fillinglyophilizationGMPlean six sigmacapexoperational readiness

Deal Breakers

No hands-on aseptic manufacturing leadership, Inability to operate in a hybrid work model, Lack of experience with sterile filling/lyophilization, No familiarity with cGMP and regulatory expectations

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Associate Director, Engineering - Sterile Production Lead

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