myGwork - LGBTQ+ Business Community · 1 day ago

Principal Engineer, Process Engineering

Boston, MA

Full-time

Hybrid

Senior Level

5+ years exp

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Responsibilities

Identify and develop technical solutions to enable program and company goals.

Lead the design and implementation of efficient and scalable manufacturing processes for commercial application, working closely with cross functional teams including process development, manufacturing, and engineering. The role includes the design and execution of process scale-up strategies and technologies, with the potential to design and implement novel equipment and manufacturing platforms for cell therapy programs. This includes the assessment of advanced automated systems, including robotics, artificial intelligence, and digital data systems.

Establish process equipment selection and user requirement specifications to enable efficient facility installation and qualification.

Drive continuous improvement activities and operational excellence, including reduction of Cost of Goods Sold (COGS) and commercial robustness/reliability.

Qualification

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Equipment DesignFAT/SATsQualificationValidationProject ManagementGMP ManufacturingFacility DesignProcess Fit/Transfer MethodologiesAutomated Inspection SystemsCGMP RegulationsRegulatory Agency InspectionsProcess Analytical TechnologiesManufacturing Performance AssessmentExternal Partners CollaborationProcess AutomationRobotics

Required

PhD with 5+ years, MS with 7+ years, or BS with 9+ years of experience

Significant experience leading equipment design, FAT/SATs, qualification, and validation

Experience leading projects with minimal oversite

Experience with large-scale GMP manufacturing for biopharmaceutical manufacturing, specifically facility design and process fit/transfer methodologies

Knowledge of vision or other automated inspection systems

Experience with cGMP regulations/guidance and with regulatory agency inspections preferred

Experience with inline process analytical technologies (PAT) for real-time assessment of manufacturing performance is preferred

Experience working with external partners (CMOs, vendors, etc.)

Ability to travel, nationally and internationally, up to 10 - 15%

Flexibility to work on-site a minimum of 3 days per week