Role: Chemical Engineer
Experience: 10+ years
Location: remote
Overview
The Chemical Engineer who will support and train and the development, optimization, and oversight of pharmaceutical manufacturing processes. The role focuses on ensuring safe, compliant, and efficient production while maintaining strict quality standards. The position requires hands-on problem-solving, solid technical judgment, and an understanding of regulated environments.
Key Responsibilities
- Develop, scale-up, and optimize chemical and formulation processes for API or drug-product manufacturing.
- Support technology transfer from R&D to manufacturing, ensuring process parameters are well-defined and robust.
- Conduct root-cause analysis and implement corrective/preventive actions for process deviations or equipment inefficiencies.
- Prepare and review technical documents, including batch records, SOPs, process descriptions, and validation protocols.
- Collaborate with QA, QC, Manufacturing, and Validation teams to maintain compliance with GMP and regulatory requirements.
- Perform risk assessments (FMEA, HAZOP) and ensure process safety standards are upheld.
- Monitor process performance and drive continual improvement initiatives.
- Participate in equipment selection, qualification, and commissioning for new or upgraded production lines.
