Pharma Manufacturing Engineer - Packaging & Compliance

Granules Pharmaceuticals, Inc.; Chantilly (VA); On-site; USD 60,000 - 75,000; Full time

Job summary

Granules Pharmaceuticals Inc. in Chantilly, VA seeks a Manufacturing Engineer to design, qualify, and implement manufacturing systems for pharmaceutical products, including packaging design.

You will collaborate across Operations, Quality, Regulatory Affairs, and Supply Chain on new product launches and cost optimization. The ideal candidate has 3–5+ years in a regulated environment, familiarity with cGMP, and experience with equipment qualification, supplier management, and FDA compliance.

Qualifications

• 3 to 5+ years of manufacturing engineering experience in a regulated environment.
• Experience with manufacturing operations, development, and specifications.
• Experience with suppliers and contract manufacturers.

Responsibilities

• Evaluate manufacturing and packaging materials and components for bottle packaging.
• Develop manufacturing solutions that improve product protection, manufacturability, 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 info are accurate on materials.
• Maintain manufacturing documentation in compliance with FDA, cGMP, and quality systems.
• Initiate and support Change Controls, Deviations, CAPAs, and qualification activities.
• Prepare manufacturing cost analyses and bids for opportunities.

Skills

Excel Proficiency

Serialization Knowledge

Regulatory Compliance

Quality Systems

Manufacturing Knowledge

Education

Manufacturing Engineering

Manufacturing Science

Mechanical Engineering

Industrial Engineering

Materials Science

Chemical Engineering

Tools

TOPS palletization software

SAP ERP

Job description

Granules Pharmaceuticals Inc. in Chantilly, VA seeks a Manufacturing Engineer to design, qualify, and implement manufacturing systems for pharmaceutical products, including packaging design.

You will collaborate across Operations, Quality, Regulatory Affairs, and Supply Chain on new product launches and cost optimization. The ideal candidate has 3–5+ years in a regulated environment, familiarity with cGMP, and experience with equipment qualification, supplier management, and FDA compliance.