NEERAJ SHARMA
Chandigarh
Summary
Dynamic engineering leader with extensive experience at Fresenius Kabi Oncology Ltd., excelling in project management and compliance assurance. Proven track record in enhancing operational efficiency and fostering stakeholder engagement. Adept at budget management and team building, driving significant improvements in facility operations and quality standards.
Overview
27
27
years of professional experience
Work History
HOD Engineering Function (General Manager - Engineering & Projects)
Fresenius Kabi Oncology Ltd.
Kishanpura
12.2015 - Current
- Oversaw operations support for Engineering department, managing Projects and Utility section activities.
- Led operations to ensure compliance with industry regulations and quality standards.
- Developed and implemented strategic plans to enhance product availability and delivery.
- Fostered strong relationships with stakeholders to support business growth and collaboration.
- Oversaw budget management to align resources with organizational goals and objectives.
- Facilitated training programs to enhance staff skills and promote professional development.
- Maintained plant capacity of 4,800KW served by 33KVA connection.
- Managed three blocks: Cyto block (Sterile and OSD), WH, and Non-Cyto block (OSD).
- Supervised two oncology injectable filling lines with lyophilized capacities and two OSD lines (Tablet & Capsule).
- Ensured daily compliance in inventory management, budget controls, cGMP, and statutory regulations for Engineering department.
- Directed project management, preventive maintenance, and breakdown maintenance initiatives.
- Supported equipment and area qualifications, validation activities, QMS, and internal audits.
Manager – Engineering
Sun Pharmaceutical Industries Limited
Halol
07.2014 - 12.2015
- Led cross-functional teams to streamline production processes and enhance operational efficiency.
- Handled project for vial filling line with Lyophilizer, Bag filling line and Prefilled syringes in PMB block.
Manager – Engineering (R2B)
Dr. Reddy Laboratories Limited
Baddi
10.2011 - 07.2014
- Led cross-functional teams to implement strategic initiatives at Dr. Reddy Laboratories.
- Managed budgeting processes for departmental projects and initiatives effectively.
- Coached, mentored and trained team members in order to improve their job performance.
Manager (A2) – Engineering
Ranbaxy Laboratories Limited
Paonta Sahib
03.2009 - 10.2011
- Led engineering department operations to support cross-functional teams at the site.
- Handled all regulatory audits at site and represented engineering department.
Assistant Manager – Engineering
Pfizer Limited
Haridwar
04.2007 - 03.2009
- Executed the green field project for pharmaceutical manufacturing plant installation, validations and operational startup.
Sr. Officer Engineering
Fresenius Kabi Oncology Ltd.
Baddi
12.2004 - 04.2007
- Formally Dabur Pharma Ltd.
Officer - Engineering
Panacea Biotec Limited
Lalru
02.2001 - 12.2004
- Led operations and maintenance of pharmaceutical water systems and HVAC systems with BMS-controlled SCADA for a vaccine manufacturing facility.
Project Assistant
Institute of Microbial Technology (IMTECH)
Chandigarh
09.1998 - 01.2001
- Project Assistant in Fermentation division.
- CSIR Lab
Education
B. Tech. - Electrical Engineering
Karnataka University
03-2013
Safety trained professional - Safety Work Streams, Electrical Safety,
DuPont Safety Institute
03-2012
Diploma - Instrumentation Engineering
Govt Polytechnic Kangra
Himachal Pradesh06-1998
High School Diploma -
Govt Polytechnic Kangra
Himachal Pradesh04-1994
Project Management D Certificate - Project Management
Project Management Institute
New Delhi, INDIASkills
- Engineering management
- Compliance assurance
- Project and budget management
- Quality control
- Stakeholder engagement
- Facility operations
- Change management
- Team development
- Process automation
- Cost reduction strategies
- Risk management
- Leadership skills
- Financial expertise
- Budget oversight
- Performance enhancement
Professional Snapshot
Engineering professional with rich experience in pharmaceutical plant operations, engineering, and projects, successfully handled critical assignments in facility engineering, plant revamping, process engineering, utility operations, and projects: design and commissioning Over 25 years' experience having demonstrable knowledge in operations and projects in parenteral manufacturing facilities for small volume parental (aseptic formulations), (cytotoxic / non-cytotoxic), high potent molecules (HPD), and immunosuppressants facilities
- Lyophilization (IMA, Tofflon, GEA, BOC Edwards, Usifroid, LSI),
- cRABS / isolators / FFM (Steriline, M+W, SCAN),
- VHP decontamination (STERIS, Steriline, AMERA, and Fedegari),
- Glove integrity testing systems (Steriline, TYLIN, TEMA),
- Injectable filling Line (Groninger, MAR, Steriline, Macofar / Romaco),
- Aseptic Bag Filling (LVP – Plumet),
- Pre-filled syringes line (Groninger / BOSCH),
- Sterilizers / bung processors (Fedegari, Pharmalab, Machine Fabric, Indo German, Metalchem),
- Online particle counters (Met One / PMS),
- Single pot processors (GEA Pharma systems), bin blenders (Buck Systems / SAAN Engineers),
- Tablet compression machine (GEA, FETTE, SEJONG, CADMACH),
- Wruster coaters (PAMM Glatt, Anish), coaters (Gansons, Bectochem, Newcota),
- Capsulation (ACG Pamm, AF40, AF90, AF150)
key skills
New set-ups, process control, machine automation, re-engineering activities, operational excellence, project management, spares management, engineering design, process safety measures, environment management, QMS implementation, MIS reports, productivity improvements, process modification, budgeting, process engineering automation, inventory control, value analysis, process scrap minimization
Dosage Forms
- Lyophilized Injectable
- Small volume parenteral (Vials & Ampoules)
- Dry Powder Injectable
- Pre filled syringes (PFS)
- Large volume parenteral (Aseptic Bag Filling)
- OSD Tables, Capsules, Pellets, Liquid Orals
- Ointments & Toothpaste
Projects Handled
- Ongoing new Project with ISOLATOR BASED Aseptic filling line for vials associated with Lyophiliser, VHP generators, inline manufacturing skid., 12/31/25
- Project completed at FKOL including Fully automatic Filling line with Isolator, VHP decontamination system., 12/31/22
- Green Field Project at Sun Pharmaceuticals, Halol having 4 lines., 12/31/15
- Green field Projects at Fresenius Kabi Oncology Ltd. for cytotoxic injectable & OSD facility., 12/31/06
- Green Field Project at Pfizer Limited, Haridwar for Beta lectum and Non-Betalectum facility., 12/31/07
- Brown Field project at Ranbaxy laboratories Ltd. For Ointments line., 12/31/10
- Brown Field project at Sun Pharmaceuticals, Halol For PMA Block Revamping under USFDA CAPA., 12/31/10
- Handled automation/safety projects at DRL Baddi., 12/31/14
Automation Initiatives
- Close transfer system for OSD areas with SCADA interface.
- BMS system installation for HVAC.
- EMS system installation for aseptic areas.
- SCADA installations for water systems.
- PMS system for PCC subs station.
- Automation of mobile racks in warehouse.
- Implementation of Preventive and breakdown maintenance through SAP PM Module.
Energy Conservation Projects
- Solar Power plant’s 300 KW.
- GAS fired boiler’s implementation.
- Condensate recovery system for boiler feed water.
- LED Lights for periphery and Warehouse.
- Energy efficient pumps in utility with VFD.
- EC blower’s implementation in HVAC units.
- HOT water for HVAC from chiller.
- EMS implementation in utility and ISO 50001 measures implementation.
Safety Aspects
- LEL and ODS detection system (HONEYWELL)
- PAFA system (HONEYWELL)
- CCTV camera system for Process area (HW)
- Electric fencing on boundary wall
Audits Faced
- USFDA Audit, FKOL, 04/01/17
- MHRA, MCC, TGA and EMA audit, FKOL, 01/01/18, 01/01/20, 01/01/22, 01/01/25
- USFDA Audit, SPIL, Halol, 09/01/14
- ANVISA, ANVIMA, MOH Russia and EU audits, 01/01/18, 01/01/22, 01/01/24
- USFDA Consultant’s Audit, LACHMEN, LEXAMED, PRTM
- Ukraine and CIS Audit, Dr. Reddy’s Labs Ltd.
- WHO GMP Audits
Trainings Workshops Attended
- DuPont Safety work stream Trainings
- PMP certification program for project management
- Operational Excellence for productivity improvement, OEE enhancement and Engineering Excellence
- Lean Six Sigma for continuous improvement
Critical Utility Machines Handled
- Boilers
- Chillers
- Cooling towers
- DG sets
- Air compressors
- Nitrogen Plant
- Heat Pumps
- Purified Water system
- Thermo-compression based WFI generation system
- Pure Steam generator
It Credentials
- MS-Office
- MS Projects
- SAP-System Applications
- Internet
- QMS software Tools like DCM, Track-wise, LMS, Auto CAD, Corel Draw
Home Contact No
09726020998
Languages
- Hindi
- Punjabi
- Gujarati
- English
- Hindi
- Punjabi
- Gujarati
Languages Known
English
Proficient (C2)
C2
Hindi
Proficient (C2)
C2
Punjabi
Intermediate (B1)
B1
Hobbies and Interests
- Music
- Travel
- Gardening
- Cricket
Personal Information
- Date of Birth: 08/29/78
- Nationality: INDIAN
- Marital Status: Married
Disclaimer
I do hereby declare that all facts mentioned above are true, correct and complete to the best of my knowledge and belief.
Certification
- Black Belt - Lean Six Sigma certification from KPMG INDIA in Nov 2025
Timeline
HOD Engineering Function (General Manager - Engineering & Projects)
Fresenius Kabi Oncology Ltd.
12.2015 - Current
Manager – Engineering
Sun Pharmaceutical Industries Limited
07.2014 - 12.2015
Manager – Engineering (R2B)
Dr. Reddy Laboratories Limited
10.2011 - 07.2014
Manager (A2) – Engineering
Ranbaxy Laboratories Limited
03.2009 - 10.2011
Assistant Manager – Engineering
Pfizer Limited
04.2007 - 03.2009
Sr. Officer Engineering
Fresenius Kabi Oncology Ltd.
12.2004 - 04.2007
Officer - Engineering
Panacea Biotec Limited
02.2001 - 12.2004
Project Assistant
Institute of Microbial Technology (IMTECH)
09.1998 - 01.2001
B. Tech. - Electrical Engineering
Karnataka University
Safety trained professional - Safety Work Streams, Electrical Safety,
DuPont Safety Institute
Diploma - Instrumentation Engineering
Govt Polytechnic Kangra
High School Diploma -
Govt Polytechnic Kangra
Project Management D Certificate - Project Management
Project Management Institute