Pilot-Scale Chemical Process Engineer for GMP API

Wilmington PharmaTech Company; Newark (DE); On-site; USD 90,000 - 120,000; Full time

Job summary

Wilmington PharmaTech is seeking a Chemical Process Engineer to support development, scale-up, and execution of manufacturing processes for API production. You will own pilot-scale manufacturing workflows, identify risks, and drive continuous improvement in a cGMP environment.

You will collaborate with Process Chemistry, Manufacturing, QA, and Facilities to deliver robust processes, write batch records, and ensure line readiness.

Qualifications

• Bachelors degree in Chemical Engineering or closely related engineering discipline.
• 05+ years of experience in process engineering, manufacturing, or chemical operations in pharmaceutical, API, or CDMO environments.
• Working knowledge of cGMP manufacturing, validation, and quality systems.
• Strong written and verbal communication skills for technical documentation and cross-functional collaboration.

Responsibilities

• Pilot Plant & Batch Production Support: develop and implement manufacturing processes for scale-up and product development.
• On-Floor Manufacturing Support: assist production operators with real-time technical guidance and troubleshooting.
• Batch Record Authoring: write, review, and improve batch records and related documentation.
• Line Clearance & Readiness: perform line clearance checks to ensure equipment and facilities are prepared for production.
• Process Safety, Validation & Equipment Qualification: conduct process hazard analyses and validations; write protocols for equipment qualification.
• MP Documentation & Quality Collaboration: draft GMP documentation and collaborate with QA to ensure cleaning, documentation, and release of equipment.
• Audit & Inspection Readiness: support regulatory inspections and internal audits as SME.
• Cross-Functional Collaboration: work with Process Chemists, Pilot Plant Operators, Purchasing, QA, and Engineering.

Skills

GMP Knowledge

Communication

Process Engineering

Cross-Functional Collaboration

Education

Bachelors degree in Chemical Engineering

Advanced degree preferred

Job description

Wilmington PharmaTech is seeking a Chemical Process Engineer to support development, scale-up, and execution of manufacturing processes for API production. You will own pilot-scale manufacturing workflows, identify risks, and drive continuous improvement in a cGMP environment.

You will collaborate with Process Chemistry, Manufacturing, QA, and Facilities to deliver robust processes, write batch records, and ensure line readiness.