Continuing Professional Development

I have completed Master of Science in Pharmaceutical Operation & Management from BITS Pilani, India and Bachelor of Chemical Engineering from Mumbai University, India. I have attained distinction in my graduation as well as post graduation course. I have experience in production, management and development of API or active pharmaceutical ingredients. I have an exemplary knowledge of process engineering that can be used in successfully executing various projects. My hands-on experience in the manufacturing sector of API makes me capable to handle various kinds of projects. My strong focus on the quality control as well as compliance according to specifications can help me to achieve project and organizational objectives. I have the capability to manage workload and prioritize tasks. My strong leadership skill enables me to manage and motivate various teams and units for getting the desired output. I have the ability to complete my tasks within given time. I have strong analytical skills that can be used for investigation purpose and analytic evaluation. My exemplary written communication skills can be used for preparing technical and project reports. I have strong verbal and technical communication skills that can be appropriately used for preparing power point presentations. I can effectively use my interpersonal skills to negotiate with people and handle multi-disciplinary teams. I have the ability to effectively communicate plans and activities with my subordinates and supervisors. I can generate creative and innovative ideas for accomplishing goals and objectives. I have exceptional critical thinking ability that can be used for solving complex issues. My decision making ability has always played a crucial role in making accurate strategic plans for achieving goals and objectives of any project. I always seek to pursue a challenging as well as rewarding career and be a part of a well-reputed, dynamic organization for enhancing and utilizing my technical and managerial skills. Therefore, I want to apply to Australian Immigration (Engineer Australia) for incrementing my practical knowledge, skills and competencies.

Academic Qualification

Work Experience

Professional Engineering: Summary Statement

CE 3.1 Project Information

Name of the project: Reduction of Process Variability by Implementing Six Sigma Tools

Location of the project:  Mandideep, Bhopal, Madhya Pradesh, India

Project Duration: From June of 2016 to Present

Organization: Lupin Limited

 Role and Designation during the time: Deputy General Manager

CE 3.2 Project Background

CE 3.2.1 Characteristics of the project

This project was undertaken at the Production Unit 2 of Lupin Limited at its Mandideep location. The turnover of this site of Lupin Limited is AUD 40 million approximately. Unit 2 of this pharmaceutical company is responsible for the production of Cardiovascular API or Cardiovascular Active Pharmaceutical Ingredient. Lupin Limited is known to be the largest manufacturer of Lisinopril. The other major products of the Mandideep production site are Ramipril, Quinapril, Benazepril, Perindopril and Trandolapril. This unit was founded in 1988. The plants of this unit have been expanded with time. There was no scope for more production in this Mandideep site. Pharmaceutical businesses generate savings and revenues by launching new molecules because there are few competitors during the product launch. Lupin Limited consists of old molecules. It would be able to generate more revenue by reducing the process variability by implementing Six Sigma tools that will facilitate the launch of new molecules.

CE 3.2.2 Objectives developed for the project

Six Sigma is considered to be a quantitative as well as a qualitative technique for improving the process of an organization. The main objectives of this project were:

• To reduce the variability of the processes
• To improve the internal processes on a continuous basis
• To increase customer satisfaction and improve customer loyalty
• To help in time management and improve business efficiency
• To reduce cycle time of projects and find effective solutions for complex issues
• To effectively use the Six Sigma techniques and tools for promoting employee development and motivate the employees
• To eliminate unnecessary complexities and increase yields
• To eliminate unnecessary costs

CE 3.2.3 My area of work

Lupin Limited had appointed me as the Deputy General Manager of the Production Unit 2, which is located in Mandideep, India. My main area of work was to supervise the production activities that were carried out in Unit 2. My team involved a senior manager and three managers who had to directly report to me. There were other executives working under their supervision. I had to manage a team of total 166 professionals and ensure that the objectives of the project were accomplished within the given budget and time.  My area of work involved reviewing of process capability and carrying out cost analysis. I had to review the non-confirmatory of the old products. I had to report to the site head regarding the progress of the project. I had to ensure that the variation in yield was reduced. My main area of work was to implement Six Sigma tools for achieving the objectives of the project.

CE 3.2.4 Project Group

Figure 1: People involved in the project

CE 3.2.5 My responsibilities throughout the project

My main responsibility was to ensure the efficacy as well as the quality of products. I was responsible for monitoring the cost of the activities and ensuring the safety of the employees. It was my responsibility to engage the employees in the project and ensure that different platforms were accessible for promoting the active participation of the employees. I had to develop ideas for encouraging the employees to feel involved in the project via suggestion schemes, talent review and development of leadership skills. I was responsible reducing the attrition rate of the organization through various schemes such as promotion and incentive plans. I was given the responsibility to optimize the cost of project activities by implementing Six Sigma techniques and tools. I had to monitor the activities of the team members and ensure that the manufacturing operations met the manufacturing practices. I had to make the plant ready for facing regulatory audits such as USFDA, WHO and MHRA along with customer audits at any time. I was responsible for reviewing the volume as well as revenue generation for prioritizing intermediaries. I had to check the variability of yield for Lisinopril production for the financial year 2016. I had to work on the four steps of Lisinopril production that had high variability. One of my key responsibilities was to develop the team members and improve their effectiveness. I had to ensure that the team members have sufficient skills and knowledge for overcoming future challenges.  I was responsible for strengthening the project team and ensuring the reduction in variability within the given budget and time. I was given the responsibility to form teams, and different people were assigned different responsibilities for the execution of this project. I had to follow the DMAIC method of Six Sigma for ensuring high quality process. I was responsible for forming cross-functional teams and departments and reviewing the project progress. I had to give a regular update the project status to the top management team on a quarterly basis. I had performed value stream mapping of the processes. Cause and effect matrix was also developed by me. I was given the responsibility to decide the data collection points and perform data analysis. I had to define the actionable points and carry out trials for improving the phase. One of my main job responsibilities was to identify good opportunities and implement them for achieving the project objectives.

CE 3.3 Distinctive Activity

CE 3.3.1 Detailed Technical Approach to project: Task Performed and Major Findings

Minitab simulation helped to determine that there was a direct correlation of the yield with respect to the reaction conversion that used Pd/C as its catalyst. I had identified that the main cause of the high variation catalyst poisoning due to the presence of sulphur in Pivonyl Chloride. I had negotiated with the vendors and finalised a limit of NMT 0.05 percent of sulphur dioxide in Pivonyl Chloride. This led to the reduction in the variation and improvement of yield. High variation was found during dispensing of the liquid intermediate from one vessel to another. I had recalibrated the MOC PPFRP vessels as it had a bulging tendency. This resulted in the reduction of the standard deviation by 25 percent. There was low yield during summer months that led to a high standard deviation. I had found out by studying the drug development report that there was formation of impurity at high temperature. I had calculated the load of utility and proposed to run the condenser on cooling water rather than chilled water that led to the improvement of yield by 2.5 percent. I had introduced a targeted parameter range within the limits of process parameters that helped in identifying the main cause of temperature variation in the processing parameters of the intermediate.

CE 3.3.2 Engineering Knowledge and Skills applied in the project

I have applied my technical skills and knowledge for the accomplishment of this project. I have utilized my skills to apply the Six Sigma tools for reducing the yield variability. I have utilized my process engineering knowledge to calculate the utility load for all the steps during the summer months for reducing variability and standard deviation in process. I have applied my interpersonal skills to effectively communicate with the suppliers and the team members.

CE 3.3.3 Accomplishment and result

I was able to reduce the yield variation by 27 percent in all the four stages against a target of 30 percent variation reduction. There was more than 30 percent reduction in variation in two of the identified stages. Other two stages are being worked upon till present for further variation reduction. Processes have been controlled through automation and revision of batch production record for achieving long-term stability of the success. Analytical regression carried out by Minitab simulation made it evident that the actions were prominent and ensured its sustainability.

CE 3.3.4 Identified issues and their solutions

CE 3.3.4.1 Issues

Some of the processes required huge manpower. This had made the processes vulnerable to variation.

CE 3.3.4.2 Solution

This issue manpower was resolved by automating processes such as distillation, crystallisation and pH adjustment that helped in reducing variation. Minor corrections were also done at various stages for ensuring project success.

CE 3.4 Project review

CE 3.4.1 Project overview

This project was about reducing process variability at the Production Unit 2 of Lupin Limited. Six Sigma tools have been applied to achieve the objectives of the project. This approach was able to improve the process yield and reduce its variability in two identified steps by 27 percent. Implementation of Six Sigma tools has facilitated the launch of new molecules.

CE 3.4.2 My contribution to work

My contribution to the project activities played a significant role in its success. I had mentored members belonging to different teams and develop their skills. I have made an in-depth investigation to perform root cause analysis. My exemplary interpersonal skills have played a major role in interacting with cross-functional teams. I have guided them and kept them motivated for achieving the goals of the project. My technical skills and knowledge were appreciated by the site head and the top management team.

CE 2.1 Project Information

Name of the project: Increase of Active Pharmaceutical Ingredient (API) Production Plant Capacity

Location of the project: Tarapur, District Palghar, Maharashtra, India

Project Duration: From February of 2013 to September of 2013

Organization: Lupin Limited

Role and Designation during the time: Production Manager

CE 2.2 Project Background

CE 2.2.1 Characteristics of the project

This project was undertaken by Lupin Limited for increasing the capacity of the production plant of an API or Active Pharmaceutical Ingredient, Losartan Potassium. Losartan is used for treating patients who are suffering from high blood pressure or hypertension. It also lowers the risk of heart attack or stroke. The API production plant was located in Tarapur, District Palghar, Maharashtra, India. Lupin Limited was founded in the year 1968, and this production site was commissioned in the year 1992. This pharmaceutical company is known to have API along with formulation plants. The turnover of this company was USD 2.5 billion in the financial year 2017. This project started in February 2013 and was completed in September 2013.

CE 2.2.2 Objectives developed for the project

The main objectives of this project were:

• To increase the production plant capacity of Losartan Potassium
• To achieve maximum utilization of resources
• To optimize the throughput of the existing production plant

CE 2.2.3 My Area of work

I was appointed by Lupin Limited as the production manager of this project. My involvement in this project was from February 2013 to September 2013. I had to report to the site head. My main area of work consisted of increasing the production plant capacity for maximum utilization of resources in terms of capital investment as well as throughput. I was accountable for all the activities related to production as well as solvent recovery plant. My area of work involved directing and supervising a team of 70 people. I had to distribute their jobs and responsibilities based on their skills. Monitoring the productivity of production units and quality, as well as compliance of the production units, was included in my area of work. I had to ensure that the plant occupancy was optimized, its capacity was expanded and the investment was minimal.

CE 2.2.4 Project Group

                                  Figure 1: People involved in the project

CE 2.2.5 My responsibilities throughout the project

My responsibilities were equally distributed among all the phases of this project. I was responsible for transferring technology and commissioning the products. I had to ensure that the products are correctly produced at the first time. I had to rigorously review the exhibit batches, plant modifications and production for meeting and satisfying the requirements. I was responsible for thoroughly reviewing the process of maintaining the cost and safety. It was my responsibility to prepare engineering drawings. The site head had given me the responsibility to coordinate with various departments such as research and development, project teams and maintenance department for proper execution of the project plan and activities. I had to generate progress reports and monitor the activities of the team members. I was responsible for resolving conflicts and motivating my team members so that the objectives of the project were achieved within the given time.

CE 2.3 Distinctive Activity

CE 2.3.1 Detailed Technical Approach to project

I began with the process improvement technique called ‘Gemba’ for getting an insight into the work standard and process. To overcome the issue of the slow process of cooling of the reactor, I had proposed to charge caustic flakes and water. In parallel to this, cooling of reactor mass was also proposed before charging the starting material. In this proposal, the solution was not degraded at a higher temperature and hence this proposal was accepted by the regulatory and process department. The key material was added after attaining the required temperature. The cooling of the reactor was occurring at a fast rate. Spray dryer was used to produce the amorphous product.  I had increased the size of the nozzle of the cleaning feed and arranged the spare jet nozzle set that was cleaned offline for saving cleaning time. This had increased the capacity by 5 percent. I was able to increase the temperature of the spray dryer chamber by 10 deg C with the help of HAZOP study.  There was 14 percent rise in the plant capacity by making minor changes in the process parameters. I had proposed to use refluxing toluene layer into the system rather than putting fresh toluene for the dehydration purpose. The solvent charging time was reduced along with the solvent quantity. This reduced the time cycle and increased the plant capacity. Activities were reshuffled for the purpose of reducing occupancy of the bottleneck equipments. I had improved the utility system and carried out troubleshooting for improving the efficiency of the equipments.

CE 2.3.2 Engineering Knowledge and Skills applied in the project

I have utilized my process engineering experience in accomplishing this project. I have applied my process engineering skills and knowledge for enhancing the throughput of the existing equipments and reducing the capital investment. My engineering skills helped me to review the capacity of the existing equipment and review its efficiency. I have utilized my project handling skills to break down each activity time. I have utilized my project management knowledge for using the Six Sigma tools, Kaizen and TPM to get a consistent throughput. My technical skills have helped me to identify non-value added activities and take actions to reduce such activities. I have excellent knowledge of equipments that has helped me to identify bottleneck equipment and shift workload to low occupancy equipment.

CE 2.3.3 Accomplishment: task performed and results

The project was accomplished within given time. Some of the bottleneck equipments were idle as they were waiting for the completion of other sub-activities that was consuming more time due to manual labour such as material unloading. Reengineering of material handling was done and auto material transferring was introduced for optimizing this situation. Manpower Optimisation Sequence Technique or MOST study was performed for motivating the team to look into manpower deployment with a fresh view. Initially, the team felt that this was a way to reduce manpower. I had motivated my team members to learn the technique and understand the benefit by making them aware of the fact that enhancement in manpower effectiveness was different from manpower reduction.  I had removed the non-value activities and reduced the physical load of the people by introducing automation. I had explained the team members that value addition and increase in manpower effectiveness would increase the effectiveness of plant as well. This exercise initially led to the reduction of 3 percent manpower and after the introduction of automation, 6 percent manpower had reduced. The increase in throughput of the plant was about 18 percent. The plant is said to give better performance for the last 4 year after its capacity has been revised.

CE 2.4 Project Review

CE 2.4.1 Project overview

This project was about increasing the capacity of the production plant of an API or Active Pharmaceutical Ingredient. It was undertaken by a well known pharmaceutical company, Lupin Limited. The production plan is located in Maharashtra, India. This project was undertaken in February 2013 and was accomplished by September 2013. The project objective of increasing production plant capacity of Losartan Potassium and maximizing resource utilization was achieved through effective planning and collaborative activities of the project team members and other relevant departments.

CE 2.4.2 My contribution to work

I made major contributions to the project. I had revised the increased capacity in budgeted figures and had made OEE calculation a part of monitoring for carrying out regular review of the deliverance at the revised standard.  These changes led to cost reduction. I was appreciated by the site head and the senior management team for procedural corrections as well as cost reduction. My leadership skills were utilized in the process of team management. I played a critical role in negotiating and communicating with other departments for the progress of the project activities. My strong communication and interpersonal skills helped me to articulate my perspective in a systematic manner. I was able to effectively handle the manpower and motivate them to enhance their effectiveness for the purpose of achieving the objectives of the project. I taught those lessons so that they can become an entrepreneur and work in an efficient manner for achieving short term as well as long-term goals. During the tenure of this project, I was able to enhance my knowledge of scientific techniques and apply MOST and OEE for reviewing the future scope of the project. I was able to find creative solutions to critical issues and also helped in modifying previously scheduled plans and activities. I had utilized my interpersonal skills to encourage my supervisor and subordinates to work in a collaborative manner that led to the accomplishment of this project. I had reviewed and monitored all the production related activities in an effective manner and also had actively monitored the progress of the project work. My hard work and dedication played a significant role in the success of the project.

CE 1.1 Project Information

Name of the project: Expansion of Effluent Treatment Plant or ETP

Location of the project: Mandideep, Bhopal, Madhya Pradesh, India

Project Duration: From 2005 to 2010

Organization: Lupin Limited

Role and Designation during the time: Process Engineer

CE 1.2 Company Background

Lupin Limited is a well reputed pharmaceutical company that is headquartered in Mumbai, India. The overall revenue of the company was USD 2.5 billion in the financial year 2017.  This project work was undertaken in the environmental area of Lupin Limited situated in Mandideep, Bhopal, Madhya Pradesh, India. This site is responsible for generating USD 800 million of revenue for Lupin Limited.

CE 1.3 Project Background

CE 1.3.1 Characteristics of the project

This project was undertaken to expand the ETP in the Mandideep site of Lupin Limited. The duration of this project was from 2005 to 2010. It took five years to complete all the project activities and expand the ETP. The total budget of this project was INR 12 crore or AUD 2.4 million. The Mandideep site of Lupin Limited was under the process of expanding its production plants. This site was considered to have no liquid discharge. The expansion of production plants increased the generation of effluent which led to the requirement for expanding ETP or effluent treatment plant.

CE 1.3.2 Objectives developed for the project

This project was undertaken for carrying out the expansion of effluent treatment plant in the Mandideep site of the pharmaceutical company called Lupin Limited. The main objectives of this project were:

• To improve the quality of recycle water so that it can be treated in the ETP that will be usable for boiler as well as cooling towers
• To reduce the hauling cost as well as the cost of offsite treatment
• To eliminate the unnecessary usage of water during processing
• To effectively recover production materials from waste streams and reduce supply costs
• To increase the capacity of sewer
• To protect the environment
• To localise the treatment as well as dispersal of effluent
• To reduce the expenses related to operations and maintenance
• To reduce the purchase of water from water suppliers

CE 1.3.3 My area of work

I was appointed as the process engineer under the Process Engineering Department. I was working under the supervision of the senior manager of Process Engineering Department. I was involved in this project from 2005 till 2010. Being the process engineer, my main area of work was to ensure that the unit operations in ETP plant were running smoothly. I had to conceptualize new projects and ensure the efficiency of the unit processes. One of my main areas of work was to work on the daily troubleshooting of ETP plant. I was accountable for the expansion of ETP. My area of work was also to motivate the team members and monitor their activities so that the project work was completed within time.

CE 1.3.4 Project Group

Figure 1: People involved in the project

CE 1.3.5 My responsibilities throughout the project

I had various responsibilities throughout the project. My main responsibility was to conceptualize the plan for ETP expansion. I had to evaluate the capability of the existing plant to determine the need of expansion along with the specifications. I was responsible for understanding the needs of the internal customers and determining the regulatory requirements. The senior manager had given me the responsibility to take quotations from various vendors. It was my responsibility to make changes and modifications based on the requirement of Lupin Limited. I had to evaluate different technologies and make a techno-commercial report based on the feasibility of the technologies. I was responsible for preparing estimated budget and cost. I had to negotiate with the vendors based on the estimated cost. I was given the responsibility of procurement as well as the installation of equipments. I was responsible for commissioning the project. One of my main responsibilities was to coordinate and align various departments and stream teams such as purchase department, electrical and civil engineering departments. I had to prepare project progress report along with the technical feasibility report. I was given the responsibility to carry out the documentation process. I had to supervise the activities of the team members and give them proper direction so that the project work was completed within given time.

CE 1.4 Distinctive Activity

CE 1.4.1 Engineering knowledge and skills applied in the project

I have utilized my chemical engineering skills to accomplish this project. This Greenfield project utilized the knowledge and skills of expertise of various engineering streams such as electrical, civil and mechanical engineering. I have exemplary interpersonal skills that helped me to negotiate with the external and internal customers as well as the vendors. I have applied my critical thinking ability and problem solving skills to develop long-term strategy. I have utilized my written communication and technical skills for preparing technical proposal and reports. My project handling skills helped me to meet complete the project work on time and within given budget. My detailed engineering knowledge was applied for making process flow diagrams.

CE 1.4.2 Accomplishment and task performed

Effective planning led to the accomplishment of this project. The capacity enhancement of ETP was done by increasing the biological as well as the dissolved solid separation system or set up. Diffused aeration was found to be better than surface aeration. This project had focused on oxygen aeration which was a new technology and it was never used in India. I got an insight into this technology by visiting European countries and seeing the plants that were based on this technology. Spin flash dryer was used for handling sludge from the ETP. Reverse osmosis, agitated thin film dryer and multi-effect evaporator were used for recycling water from the waste and making it suitable for recycling into the cooling tower. I had carried out techno-economical evaluation and comparison of the five-stage multi-effect evaporator versus the seven -stage multi-effect evaporator. Agitated thin film dryer was used for final concentration of effluent.

CE 1.4.3 Identified issues and their solutions

1.4.3.1 Issues

The existing spiral bound membrane technology had high floor requirement, high operating cost and low throughput. The stainless steel chosen during the initial project was showing problem after two years. The agitator blade was falling.

1.4.3.2 Solutions

I had performed trial and error tests and decided to procure the disc tube type of reverse osmosis plant. This was treated through one more reverse osmosis plant. DTRO solved the issue of spiral bound membrane technology. To overcome the problem of stainless steel, I had performed coupon test of alloy-20, hastealloy and titanium. I had chosen hastealloy as it is cost economical and has a high shelf life. This had reduced the maintenance activity to a large extent.

CE 1.5 Project Review

CE 1.5.1 Project Overview

The expansion of ETP project was a Greenfield project. The total cost consumed for expanding ETP was AUD 2.4 million. The project began in 2005 and was completed in 2010. Being the process engineer, I played the most important role in coordinating the activities of the project and achieving success within the given deadline. The expansion of production plants in the Mandideep site of Lupin Limited increased the generation of waste. Initially, this site was considered to be a zero liquid discharge site. The expansion of ETP was needed because of this reason. This project was able to improve the quality of the recycle water for treating it in the ETP. This water could be treated in the ETP that will be usable for the boiler as well as cooling towers.

CE 1.5.2 My contribution to work

I made a significant contribution to the success of this project. I had motivated the team members of different teams and coordinated the activities among various teams. I played a significant role in resolving their issues and aligning their activities with their targets. I ensured that the project activities were performed within the estimated budget. I have been appreciated by the senior manager, internal and external customers for my concept clarity and exceptional understanding of technical and interpersonal issues. I have used SAP software for tracking the cost and MS project for tracking the time taken for all the project activities. I had realigned the resources and prioritized various tasks for achieving project goals and objectives. I was able to generate a sustainable project. My exemplary negotiation skill has made a major contribution to this project. My conceptualised strategy of effluent treatment was a success and is still running successfully. It has been able to recycle around 450 KL of water every day. I was involved in all the phases, starting from conceptualisation to erection phase of the project and had played a significant role in achieving the project objectives. My hard work and team efforts helped in completing the project within 13.5 months, but the original plan was to complete the project work within 15 months.

Career Resume

 Personal Details

Name: Vivek Thakur

Gender: Male

Contact: +91 7770049224/+91 9826367436

Address: E-7, Fortune Shail Parisar, Near Adarsh Nagar, Hoshangabad Road, Ahmadpur, Bhopal, Madhya Pradesh, India Pin code-462026

E-mail: [email protected]

Educational Qualification

Master of Science in Pharmaceutical Operation & Management                                                       

BITS Pilani                                                                                                                  [2012]

Bachelor of Chemical Engineering                                                                          

Mumbai University                                                                                                     [1999 to 2004]

Projects Handled

1. Expansion of Effluent Treatment Plant or ETP
2. Increase of Active Pharmaceutical Ingredient (API) Production Plant Capacity
3. Reduction of Process Variability by Implementing Six Sigma Tools

Work Experience

Languages Known

• English
• Punjabi
• Hindi

Computer Skills

• Windows XP/ Vista / 7
• ChemOffice
• Microsoft Office (Word, Excel, PowerPoint, Outlook)
• DOE – Design of Experiments

Key Strengths

• Excellent communication and interpersonal skills
• Exceptional ability to work in teams
• Strong critical thinking ability and analytical skills