Chemical Process Engineer

Wilmington PharmaTech; Newark (DE); Hybrid; 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 (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

The Role

01

Pilot Plant & Batch Production Support

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 Safety, Validation & Equipment Qualification

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

MP Documentation & Quality Collaboration

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

The Candidate

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.