Khaleel Syed

DevOps Engineer

Nasik, Maharashtra, India7 yrs 8 mos experience

Highly Stable

Key Highlights

8+ years in Pharma Engineering and Automation.
Proven expertise in regulatory compliance and quality management.
Track record of delivering high-impact projects and cost savings.

Stackforce AI infers this person is a Pharmaceutical Engineering expert with a strong focus on Automation and Quality Management.

Contact

Skills

Core Skills

AutomationSmart ManufacturingProcess ImprovementQuality Management SystemPreventive MaintenanceProject Management

Other Skills

Analytical SkillsBreakdownCalibrationChange RequestsComputerized System Validation (CSV)Corrective and Preventive Action (CAPA)Customer ServiceData AnalyticsData VisualizationDigital MarketingDigital TransformationEngineeringEntrepreneurshipGood Manufacturing Practice (GMP)Industrial Engineering

About

👨‍🔧 Pharma Engineering | Automation | Reliability | CSV | Smart Manufacturing 🔹 8+ years of experience in Sterile and OSD manufacturing with global pharma leaders – Cipla, Sanofi & GSK. 🔹 Proven expertise in automation, engineering operations, and regulatory compliance (USFDA, MHRA, CDSCO, WHO). 🔹 Delivered high-impact projects in equipment reliability, cost optimization, and plant efficiency. 🔹 Known for >95% equipment uptime, seamless audit readiness, and strong QMS ownership. 🔹 Successfully managed cross-functional teams and CAPEX projects in high-stakes environments. 🔹 Skilled in SAP, Veeva Vault, Power BI, and digital systems for paperless workflows and live dashboards. 🔹 Passionate about Industry 4.0, driving smart manufacturing through data-driven decisions and system upgrades. 🔹 Track record of delivering right-first-time execution, reducing downtime, and improving OEE. 🔹 Consistently upskilling in digital transformation, analytics, and operational excellence.

Experience

Gsk

Automation and Instrumentation Engineer

Jul 2023 – Present · 2 yrs 8 mos · India · On-site

Tablet Manufacturing OSD - Tablets and Eltroxin ( CDSCO, FDA)
💼 Automation Engineer (CSV Projects and Smart Manufacturing)
🛠️ Key Projects & Achievements
☞ Digital IPQC Integration: Delivered end-to-end execution from Design, Architecture to IQ/OQ, achieving right-first-time qualification.
☞ BMS System Upgrade (Schneider): Executed full migration from TAC Vista to EBO with smart servers in just 8 days using SMED principles, minimizing downtime.
☞ FBD (Sapphire) Control Upgrade: Upgraded control system to 21 CFR compliance, enhancing regulatory readiness.
☞ Diosna FBD Drying Time Optimization: Applied DMAIC methodology, reducing drying time from 140 to 116 minutes, improving batch output and OEE.
☞ Paperless Calibration System: Led implementation and data collection initiative, reducing manual efforts by 70%.
☞ Automation Dashboard Development: Designed Power BI dashboard for real-time tracking of activities.
☞ Control Logic Enhancements: Updated FBD and Diosna logic programs for process improvements and reliability gains.
☞ Vendor Engagement: Created detailed RFQs for multi-vendor projects, aligning execution with financial and timeline goals.
☞ Kaizen & Gemba Projects: Actively engaged in process improvements, reducing manual interventions and error rates.
☞ Improved OEE by enhancing asset lifecycle management for automation systems in Tablet and Eltroxin manufacturing lines.
☞ Delivered departmental R&M budget within target, optimizing costs without compromising reliability.
☞ Sustained zero repeat deviations in the ownership area by ensuring timely RCA, CAPA closures, and proactive compliance
☞ Successfully onboarded new vendors through TPRM, managing supplier requests and gate pass processes via SAP and Fiori.
☞ Ensured continuous regulatory compliance and data integrity through proactive audits and system monitoring.
☞ Upskilled through targeted workshops on Smart Manufacturing, Power BI, and Data Analytics, contributing to digital transformation.

AutomationComputerized System Validation (CSV)Smart ManufacturingPower BIRegulatory Compliance

Sanofi

Associate Engineer

Jun 2022 – Jun 2023 · 1 yr · Hyderabad, Telangana, India · On-site

Sterile Manufacturing - Insulins (USFDA, CDSCO, MHRA)
⚙️Instrumentation & Reliability Engineer – Pharma Operations
☞Ensured >98% uptime of process instruments by leading preventive maintenance and real-time issue resolution.
☞ Implemented in-house calibration methods, reducing annual calibration costs by 20% and improving turnaround time.
☞ Coordinated with Production to schedule engineering tasks without disrupting manufacturing timelines.
☞ Tracked and executed daily engineering activities to ensure compliance and operational readiness.
☞ Managed and optimized inventory of critical instrumentation spares to avoid line stoppages.
☞ Maintained and calibrated Master Instruments in compliance with GMP and internal standards.
☞ Led timely closure of QMS activities, supporting regulatory audit readiness and reducing overdue records.
☞ Reviewed and supported qualification lifecycle (URS, DQ, FAT, SAT, IQ, OQ) for new instrumentation projects.
☞ Participated in commissioning and validation of new instruments and systems as part of tech transfer and scale-up.

Preventive MaintenanceCalibrationQuality Management SystemRegulatory Compliance

Cipla

Assistant Manager

Jul 2018 – Jun 2022 · 3 yrs 11 mos · Goa, India · On-site

Sterile Manufacturing - Oncology ( USFDA, MHRA, TGA, CDSCO and WHO)
🏭 Engineering – Pharma Projects & Sterile Operations
☞ Led brownfield project execution in sterile manufacturing, improving plant efficiency and delivering 15% cost savings.
☞ Supervised cross-functional teams for CAPEX projects, ensuring on-time delivery and regulatory compliance.
☞ Managed preventive maintenance, calibration, and breakdown response for sterile equipment, achieving >95% equipment uptime.
☞ Resolved 100+ equipment issues/year, ensuring uninterrupted sterile production.
☞ Drove QMS compliance for engineering operations, supporting 100% success in internal and regulatory audits.
☞ Procured and maintained critical spares through SAP, reducing machine downtime by 20%.
☞ Monitored KPIs for sterile utilities, enabling proactive maintenance and efficiency tracking.
☞ Contributed to ISO 50001 Energy Management, achieving 8% energy reduction across sterile areas.
🛠️ Key Pharma Projects
☞ SAP ERP Implementation (2019): Digitized preventive and breakdown maintenance, cutting paperwork by 60% and improving traceability.
☞ Fedegari Steam Sterilizer Installation (2021): Delivered full installation and qualification of autoclave, boosting capacity by 30%.
☞ Aseptic Area Monitoring System Upgrade (2022): Deployed PTZ cameras and biometric access in Grade A/B zones to enhance GMP monitoring.
☞ Filling Machine Interlocking (2020): Installed NVPC-based interlocking to prevent operations during excursions, ensuring batch integrity.