Process Engineer - Pharma
Job in
Frankfort, Franklin County, Kentucky, 40601, USA
Listed on 2026-08-11
Listing for:
Intellectt Inc
Full Time
position Listed on 2026-08-11
Job specializations:
-
Manufacturing / Production
Validation Engineer, Pharmaceutical Manufacturing, Quality Engineering
Job Description & How to Apply Below
We are seeking an experienced Process Engineer – Solid Dosage to provide hands‑on manufacturing support for commercial pharmaceutical production. This role will focus on shop floor support, process optimization, PPQ activities, and technology transfer to ensure successful product launches and reliable commercial manufacturing.
Key Responsibilities:- Support PPQ (Process Performance Qualification) batches and validation activities.
- Serve as the primary shop floor technical resource during manufacturing operations.
- Support technology transfer activities from development to commercial manufacturing.
- Troubleshoot manufacturing and process issues to ensure successful batch execution.
- Collaborate with Manufacturing, Quality, Validation, and Engineering teams.
- Review manufacturing documentation, protocols, and batch records.
- Ensure compliance with cGMP and company quality standards.
- Bachelor's degree in Engineering, Pharmaceutical Sciences, or a related discipline.
- Experience supporting commercial pharmaceutical manufacturing.
- Hands‑on experience with Solid Oral Dosage (OSD) manufacturing.
- Strong knowledge of cGMP regulations.
- Excellent troubleshooting and problem‑solving skills.
- Strong communication and cross‑functional collaboration skills.
Experience:
- Tablet Compression
- Tablet Film Coating
- Granulation
- Commercial Drug Product (DP) Manufacturing
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