Chemical Process Engineer

Wilmington Pharma Tech (WPT) is seeking a Chemical Process Engineer to support the development, scale-up, and execution of manufacturing processes for API and drug substance production. This role provides hands-on technical ownership of pilot-scale manufacturing processes, translating processes into safe, scalable, and reproducible manufacturing workflows. The Chemical Process Engineer plays a critical role in risk identification, process optimization, and continuous improvement to ensure on-time delivery, product quality, and operational excellence.

The successful candidate will work closely with Process Chemistry, Manufacturing, Quality Assurance, and Facilities teams to deliver robust processes in a cGMP environment. This position reports to Operations leadership.

Responsibilities

01

Manufacturing Process Development: Develop and implement manufacturing processes to support complex product development and scale-up projects.

On-Floor Manufacturing Support: Support production operators during batch manufacturing, providing real-time technical guidance and troubleshooting.

Batch Record Authoring: Write, review, and improve detailed batch records and associated documentation for pilot plant production.

Line Clearance & Readiness: Conduct line clearance checks prior to production to ensure equipment and facilities are prepared for manufacturing.

02

Process Hazard Reviews: Lead detailed process hazard analyses, including calculations for heating and cooling requirements, off-gassing, chemical safety, and industrial hygiene considerations.

Process & Equipment Validation: Conduct process validations and support validation activities to ensure consistent and compliant operations.

Equipment

Qualification:

Write and execute protocols for new equipment qualification, ensuring readiness for GMP use.

Safety & Compliance: Ensure all process engineering activities are conducted with a strong focus on safety and regulatory compliance.

03

GMP Documentation: Draft and support GMP documentation including deviation reports, change controls, CAPAs, and related quality records.

Quality Partnership: Work closely with Quality Assurance to ensure proper cleaning, documentation, and release of pilot plant equipment before and after production campaigns and between batches.

Audit & Inspection Readiness: Support regulatory inspections and internal audits as a technical subject matter expert.

Cross-Functional Collaboration: Collaborate with Process Chemists, Pilot Plant Operators, Purchasing, QA, and Engineering colleagues to meet production and project goals.

KEY REQUIREMENTS

Education: Bachelor’s degree in Chemical Engineering or a closely related engineering discipline; an advanced degree is preferred.

Experience: 0–5+ years of experience in process engineering, manufacturing, or chemical operations within pharmaceutical, API, or CDMO environments.

GMP Knowledge: Working knowledge of cGMP manufacturing, validation, and quality systems.

Communication: Strong written and verbal communication skills, with the ability to write technical documentation and collaborate effectively with cross-functional manufacturing and quality teams.