Chemical Process Engineer
Posting Summary
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.
The Role
Pilot Plant & Batch Production Support
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Manufacturing Process Development: Develop and implement manufacturing processes to support complex product development and scale-up projects.
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On-Floor Manufacturing Support: Support production operators during batch manufacturing, providing real-time technical guidance and troubleshooting.
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Batch Record Authoring: Write, review, and improve detailed batch records and associated documentation for pilot plant production.
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Line Clearance & Readiness: Conduct line clearance checks prior to production to ensure equipment and facilities are prepared for manufacturing.
Process Safety, Validation & Equipment Qualification
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Process Hazard Reviews: Lead detailed process hazard analyses, including calculations for heating and cooling requirements, off-gassing, chemical safety, and industrial hygiene considerations.
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Process & Equipment Validation: Conduct process validations and support validation activities to ensure consistent and compliant operations.
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Equipment Qualification: Write and execute protocols for new equipment qualification, ensuring readiness for GMP use.
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Safety & Compliance: Ensure all process engineering activities are conducted with a strong focus on safety and regulatory compliance.
MP Documentation & Quality Collaboration
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GMP Documentation: Draft and support GMP documentation including deviation reports, change controls, CAPAs, and related quality records.
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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.
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Audit & Inspection Readiness: Support regulatory inspections and internal audits as a technical subject matter expert.
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Cross-Functional Collaboration: Collaborate with Process Chemists, Pilot Plant Operators, Purchasing, QA, and Engineering colleagues to meet production and project goals.
The Candidate
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Education: Bachelor’s degree in Chemical Engineering or a closely related engineering discipline; an advanced degree is preferred.
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Experience: 0–5+ years of experience in process engineering, manufacturing, or chemical operations within pharmaceutical, API, or CDMO environments.
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GMP Knowledge: Working knowledge of cGMP manufacturing, validation, and quality systems.
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Communication: Strong written and verbal communication skills, with the ability to write technical documentation and collaborate effectively with cross-functional manufacturing and quality teams.
Apply Now
For questions, early discussions, or exploratory conversations, please complete the contact form below. A member of our team will respond promptly.