Production Engineer

About the role

Granules Pharmaceuticals Inc. (GPI), a subsidiary of Granules India LTD, is a leading generic pharmaceutical company specializing in controlled substances. With sites in Chantilly and Manassas, Virginia, we handle R&D, manufacturing, and packaging of medicines, including pulsatile drug release tablets and capsules, orally disintegrating modified release tablets, modified release suspensions, and controlled substances with abuse-deterrent technology. The Manufacturing Engineer is responsible for the design, development, qualification, implementation, and continuous improvement of manufacturing systems for pharmaceutical products, including packaging design.

This role supports new product launches, manufacturing line commercialization, material selection, artwork execution, supplier management, cost optimization, and regulatory compliance. Working cross-functionally with Operations, Quality, Regulatory Affairs, Marketing, Supply Chain, Procurement, and external suppliers, the Manufacturing Engineer ensures manufacturing solutions meet FDA requirements, customer expectations, operational efficiencies, and business objectives while maintaining product quality and compliance.

Responsibilities

• 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 manufacturing components.
• Ensure SAP material numbers, component numbers, UPCs, GTINs, NDCs, lot coding requirements, and customer-specific information are accurately reflected on manufacturing materials.
• Maintain manufacturing documentation in compliance with FDA regulations, cGMP requirements, and company 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.

Requirements

• Bachelor’s Degree in Manufacturing Engineering, Manufacturing Science, Mechanical Engineering, Industrial Engineering, Materials Science, Chemical Engineering, or a related engineering discipline.
• 3 to 5+ years of manufacturing engineering experience within a regulated manufacturing environment.
• Experience supporting manufacturing operations, manufacturing development, and manufacturing specifications.
• Experience working with manufacturing suppliers and contract manufacturing organizations.

Qualifications

• OTC pharmaceutical, pharmaceutical, nutraceutical, or consumer healthcare industry experience (highly preferred).
• Experience with FDA-regulated products and cGMP environments.
• Experience supporting manufacturing validation and equipment qualification activities.
• Experience with major retail customers such as Walmart, CVS, Walgreens, Target, Costco, and Amazon.

Skills

• Strong knowledge of pharmaceutical manufacturing materials and container closure systems.
• Advanced Microsoft Excel proficiency.
• Experience with TOPS palletization software or equivalent manufacturing design software.
• Working knowledge of SAP or ERP systems.
• Knowledge of FDA regulations, cGMP requirements, and manufacturing compliance standards.
• Understanding of manufacturing line operations, serialization, labeling, coding, and inspection systems.
• Familiarity with package testing and transportation validation methodologies.