Santosh Kulkarni

CEO

India21 yrs 2 mos experience

Highly Stable

Key Highlights

Expert in leading high-volume pharmaceutical facility setups.
Proven track record in driving capital projects to success.
Strong focus on continuous improvement and operational excellence.

Stackforce AI infers this person is a leader in Pharmaceutical Engineering with a focus on capital projects and operational efficiency.

Contact

kulkarni.sk1@gmail.com LinkedIn

Skills

Core Skills

Project ManagementEngineeringManufacturing EngineeringProject EngineeringOperational ReadinessCapital ProjectsFormulation ProjectsConstruction Management

Other Skills

AccountabilityAnalytical SkillsBluebeamBudget PreparationBudgetingBuilding Information Modeling (BIM)Business EthicsBusiness Process ImprovementCAPEXCAPEX DefinitionCareer CounselingChange ManagementCloud ComputingCoaching & MentoringCommissioning

About

I'm a collaborative and results-driven engineering professional with a passion for making a meaningful impact in the Pharmaceutical, MedTech, and Biotech industries. Presently setting up greenfield facilities for high volume GLP-1 DS and DP. From leading projects through startup phases to building new organizations and implementing cGMP operations, I thrive in turning vision into reality. Creating strong, people-centric site cultures and developing systems that stand the test of time is what excites me the most. Every challenge is an opportunity to think creatively, adapt, and grow. My journey so far has been about driving innovation, fostering collaboration, and contributing to a more sustainable and forward-thinking industry - and I can’t wait to see what’s next. Over the years, I've had the privilege of driving manufacturing sites toward long-term success, nurturing growth, and tackling cross-functional challenges with a solution-oriented mindset.

Experience

Amneal pharmaceuticals

Vice President - Projects and Engineering

Oct 2024 – Present · 1 yr 5 mos · India · On-site

As Head of Capital Projects and Operational Engineering, I provide strategic leadership for engineering across eight manufacturing plants in India, spanning injectables, Onco injectable, OSD, and API facilities. My responsibilities encompass talent management, development, and retention, ensuring a high-performing, diverse team aligned with our business and strategic goals. I set and execute objectives focused on safety, quality, and operational efficiency, collaborating closely with Technical Services, Quality, and Operations to achieve production targets.
I lead major capital and technological projects, including the end-to-end delivery of a greenfield Peptide GLP-1 DS/DP facility and a 150,000-square-foot corporate office. My role involves driving the full project lifecycle—user requirements, design, build, commissioning, qualification, validation, and ongoing operation—while developing standardized engineering processes and procedures.
I ensure alignment with throughput goals, manage deviation and change processes, champion continuous improvement, and maintain performance metrics to drive operational excellence. I lead and support initiatives such as Root Cause Analysis (RCA) and Failure Modes Effect Analysis (FMEA), and engage directly with regulatory agencies during site inspections. I also influence manufacturing control strategies for formulation, filling, assembly, packaging, and logistics.
Through these efforts, I am committed to building a future-ready, sustainable engineering organization that delivers high-quality, affordable pharmaceutical products and supports the company’s long-term success.

Project ManagementEngineeringFacilities ManagementValidationGMPManufacturing+1

Johnson & johnson medtech

Site Engineering Head

Jan 2021 – Oct 2024 · 3 yrs 9 mos · India

As Engineering Head, responsible to develop and execute the engineering strategies and objectives. Ensuring flawless execution of Manufacturing engineering, Process Engineering as well as Project Engineering.
Providing leadership to the engineering team and ensure the support from all engineering functions to the day-to-day operations as well as project execution.
Responsible to ensure the integration with the regional and worldwide engineering organization at J&J.
Leading Digital transformation projects at site.

Manufacturing EngineeringProcess EngineeringProject EngineeringDigital Transformation

Gsk

2 roles

Head Of Engineering

Mar 2019 – Dec 2020 · 1 yr 9 mos

Facility: Pharma oral solid dosage, team of 75 Engineers.
Engineering operational readiness of a new state of art highly automated manufacturing facility for Pharmaceutical oral solid dosage facility. Brought together a team of 75 engineers working in different disciplines to setup operational engineering function for the manufacturing facility.
Accountable for effectively establishing and managing engineering Function at Manufacturing site, including the upkeep of Assets and facilities of the plant, through including the development & implementation of Capital Projects, Maintenance strategy, Technology up- gradations, Equipment Efficiency improvements, adherence to compliances & building people capability to achieve site KPI’s.

EngineeringOperational ReadinessCapital ProjectsMaintenance Strategy

General Manager - Global Capital Projects APAC

Oct 2015 – Dec 2020 · 5 yrs 2 mos

Global Capital Projects senior manager with experience in planning and safe,Secure(Scope,Cost,time,Safety& Quality parameters) delivery of Capital Projects.
Projects :
1. Oral Solid Dosage facility- Bengaluru, Karnataka
2. Derms Facility.- Nashik,Maharastra
3. Decommissioning & Environmental remediation of 4 old sites across India.

Capital ProjectsProject ManagementScope Management

Zydus group

3 roles

Senior General Manager - Projects & Engineering Services

Apr 2014 – Oct 2015 · 1 yr 6 mos

Lead Formulation projects. Heading team of Project managers. Was also responsible for 12 manufacturing sites engineering support for their site CAPEX definition, budget preparation and execution.

Formulation ProjectsCAPEX DefinitionBudget PreparationProject Management

General Manager- Projects & Engineering Services

Promoted

Apr 2012 – Apr 2014 · 2 yrs

Responsible for Formulation projects as a lead with key deliverables including Scope Defination,Design Management, Estimating and Cost control, Schedule and progress mgmt, Project Planning, Sourcing Strategy & mgmt., Construction management, Commissioning and Handover. Was handling a portfolio of 1200 to 1300 Crores/year with a team of 8 to 10 project managers in different disciplines(Civil, process )

Formulation ProjectsProject PlanningConstruction ManagementProject Management

Deputy General Manager- Projects& Engineering Services

Apr 2010 – Apr 2012 · 2 yrs

Responsible for Formulation projects as a lead with key deliverables including Scope Defination,Design Management, Estimating and Cost control, Schedule and progress mgmt.,
Project Planning, Sourcing Strategy & mgmt., Construction management, Commissioning and Handover

Formulation ProjectsProject PlanningConstruction ManagementProject Management

Cipla ltd.

Project & Maintenance Engineer

Jun 2002 – Apr 2006 · 3 yrs 10 mos · Goa, India

Projects and Engineering Maintenance at Cipla,Goa.
Head Engineering Maintenance, Unit IV, Cipla Goa.
Key activities :
Worked from Project stage of the facility, with responsibility of Equipment installation and MEP
services for Solid Oral facility.
Went on to become plant operational engineering (Maintenance) lead.
Hands on experience of Equipment installation, commissioning and Qualification activities
Engineering SOPs & Engineering standards harmonization across multiple plants& sites

Project ManagementEngineering Maintenance