Production Engineer

Granules Pharmaceuticals; Chantilly (VA); On-site; USD 85,000 - 120,000; Full time

Job summary

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.

Qualifications

• 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.

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 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.

Skills

FDA regulations

cGMP compliance

Cross-functional collaboration

Cost analysis

Education

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

Tools

SAP

ERP systems

TOPS palletization software

Job description

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.