Chemical Engineer
Job Title: Chemical Engineer
Location: North Carolina
Industry: Pharmaceutical Manufacturing
Job Summary:
We are seeking an experienced Chemical Engineer to support pharmaceutical manufacturing operations in North Carolina. This role will focus on process optimization, equipment performance, manufacturing support, and ensuring compliance with GMP, safety, and quality standards within a regulated production environment. The ideal candidate will have strong experience in chemical processes, pharmaceutical manufacturing systems, and continuous improvement initiatives.
Key Responsibilities:
- Provide engineering support for pharmaceutical manufacturing processes including blending, reaction, purification, and formulation operations.
- Optimize process efficiency, yield, and equipment performance to improve productivity.
- Support scale-up, technology transfer, and new product introduction activities.
- Troubleshoot process deviations, equipment issues, and manufacturing bottlenecks.
- Develop and update SOPs, batch records, and engineering documentation.
- Ensure compliance with cGMP, FDA, OSHA, and environmental regulations.
- Lead or support validation activities including IQ/OQ/PQ and process qualification.
- Collaborate with Production, Quality, Validation, Maintenance, and R&D teams.
- Participate in CAPA, change control, deviation investigations, and risk assessments.
- Support utility systems such as HVAC, clean steam, purified water, and process gases when needed.
- Drive continuous improvement initiatives using Lean/Six Sigma methodologies.
Qualifications:
- Bachelor’s degree in Chemical Engineering or related Engineering discipline.
- 3+ years of experience in pharmaceutical, biotech, or regulated manufacturing environment.
- Strong knowledge of chemical process systems and pharmaceutical manufacturing operations.
- Experience with cGMP regulations, validation, and quality systems.
- Familiarity with batch processing, reactors, filtration, drying, and mixing equipment preferred.
- Strong problem-solving, communication, and project management skills.
- Experience with process safety and environmental compliance is a plus.
Preferred Skills:
- Process optimization
- Root cause analysis
- Validation documentation
- Process automation knowledge
- Continuous improvement
- Cross-functional collaboration