Chemical Engineer - Process Improvement

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 / c

GMP, 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 Pay:

$90,000.00 - $120,000.00 per year Application Question(s): Have you supported or led CAPA investigations and root cause analysis? (Yes/No) Are you familiar with GMP / cGMP and FDA/EMA regulatory requirements? (Yes/no) Do you have experience with process validation, technology transfer, or scale-up? (Yes/No) How many years of experience do you have in chemical engineering or process improvement within manufacturing or pharmaceutical environments? Have you worked in a regulated environment (pharmaceutical, medical device, or food manufacturing)?

Location:

Davie, FL 33331 (Required)

Work Location:

In person