Senior Process Engineer

Job Title: Senior Process Engineer – API ManufacturingOverviewWe are seeking a Senior Process Engineer to provide technical leadership in API manufacturing operations. The role will be responsible for process optimization, technology transfer, scale-up, process safety, cost reduction, and ensuring reliable and compliant production within a GMP environment.Key ResponsibilitiesProcess Engineering & OptimizationLead process design, scale-up, and optimization of synthetic chemistry and API production processes.Monitor, analyze, and improve key process parameters to maximize yield, productivity, and efficiency.Apply DOE, statistical analysis, and process modeling for troubleshooting and continuous improvement.Drive implementation of new technologies and automation to enhance reliability and reduce downtime.Technology Transfer & Scale-UpLead technology transfer from R&D or pilot plant to commercial manufacturing.Support scale-up activities including process mapping, risk assessments (HAZOP, FMEA), and design reviews.Ensure process knowledge and control strategy are handed over effectively to manufacturing operations.Validation & ComplianceDevelop and execute process validation strategies, including BMR/BPR review, batch execution, cleaning validation, and equipment qualification.Ensure adherence to cGMP, ICH Q guidelines, and regulatory requirements for APIs.Maintain process documentation, SOPs, and change controls.Process Safety & Risk ManagementConduct and participate in process safety activities including HAZOP, safety reviews, and risk assessments.Support implementation of safety improvements for reactors, crystallization, filtration, and drying processes.Lead root cause analysis for deviations and support CAPA implementation.Operational Technical SupportAct as a technical SME for API operations such as:Chemical synthesisCrystallizationDistillationFiltration and dryingSolvent handlingProvide real-time technical troubleshooting and continuous manufacturing support.Cross-Functional & Project LeadershipWork closely with Production, Quality, HSE, Supply Chain, and Engineering teams.Lead cross-functional projects including debottlenecking, yield improvement, and waste reduction initiatives.Support audits and regulatory agency inspections.QualificationsBachelor’s or Master’s degree in Chemical Engineering, Process Engineering, or related field.4-6 years’ experience in API, pharmaceutical, chemical, or fine-chemical production environment.Hands-on experience with unit operations and equipment in chemical/API production.Strong knowledge of GMP, process validation, and regulatory expectations.Competent in statistical analysis tools (e.g., Minitab, JMP) and process modeling.Preferred SkillsExperience in continuous processing, automation, and PAT tools.Familiarity with ICH Q8/Q9/Q10 and QbD principles.Experience leading scale-up from lab/pilot to commercial scale.Lean Six Sigma certification is advantageous.Soft SkillsStrong analytical and problem-solving mindset.Able to communicate clearly with operators, scientists, and leadership.Leadership qualities with ability to influence and drive improvement.Proactive, hands-on, and results-oriented attitude.