Job Summary:The Manufacturing Engineer (Pharmaceutical Industry) plays a key role in supporting daily manufacturing operations, optimizing production processes, and ensuring compliance with cGMP, FDA regulations, and internal quality standards. This role works closely with Production, Quality Assurance, Validation, Maintenance, and R&D teams to improve equipment performance, implement process improvements, support new product introductions, and ensure consistent batch manufacturing for clinical and commercial drug products.The ideal candidate has strong technical problem-solving skills, experience working in a regulated environment, and the ability to support both routine operations and major improvement initiatives.Key Responsibilities:Manufacturing Support & TroubleshootingProvide daily engineering support to upstream, downstream, or sterile manufacturing operations.Troubleshoot equipment malfunctions, process deviations, and production bottlenecks to ensure uninterrupted manufacturing.Support investigations for batch failures, deviations, non-conformances, and CAPA implementation.Ensure production equipment, utilities, and systems meet operational needs and compliance requirements.Process Optimization & Continuous ImprovementAnalyze production data to identify improvement opportunities related to yield, throughput, quality, and cost.Lead Lean, Six Sigma, and continuous improvement initiatives to enhance manufacturing efficiency.Standardize processes through creation and revision of SOPs, work instructions, and batch records.Equipment & Facility ResponsibilitiesSupport equipment qualification activities (IQ/OQ/PQ) in collaboration with Validation and Quality.Participate in commissioning, startup, and troubleshooting of new equipment or facility upgrades.Maintain equipment documentation, spare parts lists, calibration requirements, and preventive maintenance plans.New Product Introduction & Technology TransferAssist in transferring new products from R&D to commercial manufacturing.Ensure processes are scalable, robust, and compliant with regulatory standards.Collaborate on process characterization, risk assessments (FMEA), and control strategy development.Compliance & DocumentationEnsure all engineering activities comply with cGMP, FDA, EMA, and ICH guidelines.Prepare engineering documents, technical reports, change controls, risk assessments, and investigation summaries.Support internal and external audits by providing documentation and technical explanations as required.Qualifications:Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Industrial Engineering, or related field.2–5 years of experience as a Manufacturing Engineer or Process Engineer in a pharmaceutical, biotech, or regulated manufacturing environment.Strong understanding of cGMP, FDA 21 CFR Part 210/211, ICH Q8-Q10, and validation principles.Experience with equipment troubleshooting, manufacturing support, and process optimization.Proficiency with technical documentation, root-cause analysis tools, and continuous improvement methodologies.Preferred Skills:Experience in sterile manufacturing, solid oral dosage, biologics, or aseptic processing.Lean Six Sigma certification (Green Belt or higher).Familiarity with automation systems (PLC/SCADA), MES, and electronic batch records.Knowledge of risk management tools (FMEA, HACCP, Fault Tree).