Chemical Engineer
GL Staffing
Davie, FloridaFull-timeMid LevelOn-site
Job Description
We are seeking a skilled Chemical Engineer to design, analyze, and optimize pharmaceutical manufacturing processes. The role involves leading process improvement and development projects, resolving complex technical and operational challenges, and ensuring compliance with Good Manufacturing Practices (GMP), quality standards, and regulatory requirements. The ideal candidate will have strong technical expertise, project management experience, and a continuous improvement mindset.
Shift / Working Hours
- Hours: 8:00 AM – 5:00 PM Mon- Fri
Key Responsibilities
- Analyze, design, and optimize pharmaceutical manufacturing processes (e.g., formulation, mixing, granulation, coating, sterilization)
- Lead process improvement and development projects from concept through implementation
- Apply structured problem-solving methodologies (Root Cause Analysis, 5 Whys, Fishbone, FMEA) to address deviations and operational issues
- Drive process improvement initiatives focused on yield, efficiency, robustness, and scalability
- Collaborate with Production, Quality, Validation, Engineering, Maintenance, and R&D teams
- Ensure all process changes comply with GMP, regulatory requirements, and quality standards
- Develop, review, and maintain process documentation, SOPs, batch records, and technical reports
- Support process validation, revalidation, and technology transfer activities
- Analyze process data and KPIs to drive continuous improvement and risk reduction
- Lead or support CAPA investigations related to process deviations, non-conformances, and OOS results
- Participate in internal and external audits (FDA, EMA, local authorities)
- Train manufacturing and technical personnel on process changes and best practices
Required & Preferred Qualifications
Education
- Bachelor's degree in Chemical Engineering
- 5–10 years of experience in chemical engineering, process improvement, or pharmaceutical manufacturing
- Proven experience in process development and project execution
- Strong technical problem-solving and root cause analysis skills
- Experience supporting validation and regulatory inspections preferred
Technical Knowledge
- Pharmaceutical manufacturing processes and unit operations
- GMP / cGMP, FDA, EMA regulations
- Process validation, scale-up, and technology transfer
- Risk management tools (FMEA, HACCP)
- Statistical analysis and process capability (Cp, Cpk)
- Process data analysis tools and advanced Excel
Apply now
Posted 2 weeks ago