Production Engineer

Description

Granules Pharmaceuticals Inc., (GPI) is a subsidiary of Granules India LTD. Over the past 34 years, we have worked towards strengthening our core and we are currently the 4th largest generic pharmaceutical company of controlled substances in the US!

With our sites in Chantilly and Manassas, Virginia, we have R&D through manufacturing and packaging of our medicines including pulsatile drug release in tablet and capsule dosage form, orally disintegrating modified release tablets (XR, MR, ER), modified release suspension and controlled substances capabilities in an abuse deterrent technology platform.

We are dedicated to excellence in manufacturing, quality, and commercialization of generic drugs to give customers reliable and affordable options.

 The Manufacturing Engineer is responsible for the design, development, qualification, implementation, and continuous improvement of manufacturing systems pharmaceutical products including packaging design. The role supports new product launches, manufacturing line commercialization, manufacturing 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.

• 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

Minimum Educational Requrements:

Bachelor's Degree in one of the following:

• Manufacturing Engineering
• Manufacturing Science
• Mechanical Engineering
• Industrial Engineering
• Materials Science
• Chemical Engineering
• Related Engineering Discipline

Required

• 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.

Preferred

• OTC pharmaceutical, pharmaceutical, nutraceutical, or consumer healthcare industry experiencehighly 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.

Knowledge, Skills, and Abilities

• Strong knowledge of pharmaceutical manufacturing materials and container closure systems.
• Advancd 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.