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 implementationApply structured problem-solving methodologies (Root Cause Analysis, 5 Whys, Fishbone, FMEA) to address deviations and operational issuesDrive process improvement initiatives focused on yield, efficiency, robustness, and scalabilityCollaborate with Production, Quality, Validation, Engineering, Maintenance, and R&D teamsEnsure all process changes comply with GMP, regulatory requirements, and quality standardsDevelop, review, and maintain process documentation, SOPs, batch records, and technical reportsSupport process validation, revalidation, and technology transfer activitiesAnalyze process data and KPIs to drive continuous improvement and risk reductionLead or support CAPA investigations related to process deviations, non-conformances, and OOS resultsParticipate in internal and external audits (FDA, EMA, local authorities)Train manufacturing and technical personnel on process changes and best practicesRequired & Preferred Qualifications
Education
Bachelor’s degree in Chemical Engineering5–10 years of experience in chemical engineering, process improvement, or pharmaceutical manufacturingProven experience in process development and project executionStrong technical problem-solving and root cause analysis skillsExperience supporting validation and regulatory inspections preferredTechnical Knowledge
Pharmaceutical manufacturing processes and unit operationsGMP / cGMP, FDA, EMA regulationsProcess validation, scale-up, and technology transferRisk management tools (FMEA, HACCP)Statistical analysis and process capability (Cp, Cpk)Process data analysis tools and advanced ExcelApply now