Chemical Engineer - Process Improvement & Operations

The Pharmacy Hub • Miami, FL

5h • $85,000 - $135,000 • Onsite

About The Position

We are seeking a highly motivated Chemical Engineer to design, analyze, and optimize pharmaceutical manufacturing processes. The successful candidate will apply chemical engineering principles to improve process efficiency, product quality, and operational performance while ensuring full compliance with Good Manufacturing Practices (GMP), quality standards, and regulatory requirements. This role involves leading process development initiatives and resolving complex technical and operational challenges in a regulated manufacturing environment.

Requirements

• Bachelor’s degree in Chemical Engineering.
• Minimum of 5-10 years of engineering experience in manufacturing environments, preferably within the pharmaceutical industry.
• Proven experience in process development and successful project execution.
• Strong background in technical problem-solving and root cause analysis.
• In-depth knowledge of pharmaceutical manufacturing processes and unit operations.
• Strong understanding of GMP, cGMP, and global regulatory requirements (FDA, EMA).
• Experience with process validation, scale-up, and technology transfer.
• Proficiency in risk management tools such as FMEA and HACCP.
• Knowledge of statistical analysis and process capability metrics (Cp, Cpk).
• Experience with process data analysis tools and advanced Microsoft Excel.

Nice To Haves

• Experience supporting process validation activities and regulatory inspections preferred.

Responsibilities

• Analyze, design, and optimize pharmaceutical manufacturing processes, including formulation, mixing, granulation, coating, sterilization, and related unit operations.
• Develop, manage, and execute process development and continuous improvement projects from concept through implementation and post-launch monitoring.
• Apply structured problem-solving methodologies (e.g., Root Cause Analysis, 5 Whys, Fishbone, FMEA) to resolve process deviations and complex operational issues.
• Lead process optimization initiatives focused on improving yield, efficiency, process robustness, reliability, and scalability.
• Collaborate cross-functionally with Production, Quality, Validation, Engineering, Maintenance, and R&D teams to ensure seamless project execution.
• Ensure all process changes and improvements comply with GMP, regulatory requirements, and internal quality standards.
• Develop, review, and maintain technical documentation, including SOPs, batch records, validation protocols, and engineering reports.
• Support process validation, revalidation, scale-up, and technology transfer activities.
• Analyze process performance data and KPIs to identify trends, reduce variability, and mitigate operational risks.
• Lead or support CAPA investigations related to process deviations, non-conformances, and out-of-specification (OOS) results.
• Participate in internal and external regulatory audits and inspections (e.g., FDA, EMA, local authorities).
• Provide technical training and guidance to manufacturing and technical personnel on process updates, improvements, and best practices.

Benefits

• Competitive salary.
• Bonus program based on productivity and efficiency.
• Opportunities for growth in a rapidly expanding telepharmacy practice.
• Collaborative and innovative work environment focused on patient safety and compliance.
• 401(k) with up to 4% matching
• Medical, dental, vision and life insurance
• Paid time off

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level