Pharma Manufacturing Engineer - Packaging & GMP

Granules Pharmaceuticals; Chantilly (VA); Presencial; USD 85.000 - 120.000; Jornada completa

Descripción de la vacante

Granules Pharmaceuticals seeks an experienced Manufacturing Engineer to design, develop, and optimize pharmaceutical manufacturing systems, including packaging and line qualifications. You will work cross-functionally to ensure FDA compliance, cost efficiency, and on-time product launches.

The role emphasizes material evaluation, specification management, SAP data accuracy, change controls, and CAPA processes, with opportunities to improve product protection and manufacturability.

Formación

• Bachelor's Degree in Manufacturing Engineering, Manufacturing Science, Mechanical, Industrial, Materials Science, Chemical Engineering or related discipline.
• 3 to 5+ years of manufacturing engineering experience in a regulated manufacturing environment.
• Experience with manufacturing suppliers and contract manufacturing organizations.
• Preferred: OTC pharmaceutical or FDA-regulated experience, cGMP environments, equipment qualification, and engagement with major retailers.

Responsabilidades

• Evaluate manufacturing and packaging materials and components for bottle packaging.
• Develop manufacturing solutions that improve product protection, manufacturability, consumer usability, and sustainability.
• Create, review, approve, and maintain manufacturing specifications for finished goods and components.
• Ensure SAP material numbers, UPCs, GTINs, NDCs, lot coding, and customer information are reflected on materials.
• Maintain manufacturing documentation in compliance with FDA regulations, cGMP, and quality systems.
• Initiate and support Change Controls, Deviations, CAPAs, and manufacturing qualification activities.
• Prepare manufacturing cost analyses and cost estimates to support commercial bids and business development opportunities.

Conocimientos

FDA regulations

cGMP compliance

Cross-functional collaboration

Cost analysis

Educación

Bachelor's Degree in Manufacturing Engineering

Bachelor's in Manufacturing Science

Bachelor's in Mechanical Engineering

Bachelor's in Industrial Engineering

Bachelor's in Materials Science

Bachelor's in Chemical Engineering

Related Engineering Discipline

Herramientas

SAP

ERP systems

TOPS palletization software

Descripción del empleo

Granules Pharmaceuticals seeks an experienced Manufacturing Engineer to design, develop, and optimize pharmaceutical manufacturing systems, including packaging and line qualifications. You will work cross-functionally to ensure FDA compliance, cost efficiency, and on-time product launches.

The role emphasizes material evaluation, specification management, SAP data accuracy, change controls, and CAPA processes, with opportunities to improve product protection and manufacturability.