Engineer Process

SUDHEER SAMI

***** **** ****** *******, ** *****

314-***-****

***********@*****.***

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OBJECTIVE Senior Process Engineer

PROFILE

. Hands on experience in bringing the product from concept to Market

. Partnership with management in defining project scope, evaluation of

alternatives, allocation of budgets, resources and timelines to

various projects

. Management of projects with CROs, CMOs, external consultants and

vendors

. Leadership of cross functional teams in R&D, manufacturing and quality

on large scale process improvement, change management and regulatory

compliance related activities

. Experience in project and process engineering (PFDs, P&IDs, URS, FRS,

FAT, CAPAs)

. Experience in sourcing and qualifying the manufacturing and pilot

scale equipment

. Experience with modeling and design of Packed bed, Fluidized bed

catalytic reactors

. Training and technical mentorship to junior engineers, research and

manufacturing personnel

. Assurance of regulatory compliance, inspections and filings

. Authored and reviewed tech review reports, DIR reports, batch records,

SOPs, FRs

. Highly motivated leader with excellent communication, presentation and

interpersonal skills

Key Skills / Software

. Project management

. Technology development

. Reactor design & Simulation

. Process Engineering & Control

. Tech transfer and scale-up

. MS Project, Visio, Power point

. ANSYS Fluent, Barracuda VR

. CFD, DOE, SPC, JMP

. MES, DCS, SCADA, PLC

. C, C++, MATLAB, CHEMCAD

PROFESSIONAL EXPERIENCE

Zyomyx, Fremont, CA

2/2010 - Present

Senior Chemical Process Engineer

. Defined project scope, communicated with senior management, allocated

budgets, resources and time lines to various scale-up and capital

projects

. Inception of capital projects, automated pilot plant systems,

analytical equipment sourcing and qualification

. Developed fluidized bed reactor technology for the manufacture of

chemical reagents

. Used CFD tools to design, model and simulate the pilot fluidized bed

reactor for scale-up of the manufacture of micro particle reagents

. Responsible for Scale-up and tech transfer of various unit operations

related to reagent manufacture to meet Pilot line production

. Managed change control, documentation revisions as required and

assisted regulatory submissions

. Led the validation (IQ, OQ, PQ) of various manufacturing equipment,

processes and test methods

. Tracked the production trends with the help of control charts (JMP)

and optimized manufacturing processes with the help of statistical

process control (SPC)

. Led and mentored a team of junior engineers

. Experienced in set up of ERP system (Part numbers, bill of materials,

inventory tracking and workflows etc.)

. Ensured regulatory compliance, supported safety, regulatory

inspections and filings

. Authored project status reports, DIR reports and pFMEA reviews and

presented to senior management

Lundbeck

12/2007 - 2/2010

Process Engineer

. Modeled and developed a novel process that uses fluidized bed reactor

for the enzymatic catalysis of pharmaceutical intermediates

. Supported the sourcing and commissioning of the new manufacturing

equipment

. Supported the tech transfer of various unit operations from pilot to

production scale

. Led troubleshooting experiments during scale-up of various unit

operations such as azeotropic distillation, liquid-liquid extraction

and leaching

. Managed various development projects with CROs and external vendors

. Performed gap analysis and initiated various process improvement

efforts to increase process efficiency in various unit operations

. Used statistical process control (SPC) software to improve the process

efficiency

. Used control charts (JMP ) to track and trend the production data

. Established procedures for the manufacturing unit operations, trained

manufacturing personnel in equipment operation, proprietary

manufacturing execution systems (MES)

University of Maryland

12/2007 - 2/2010

Graduate Research Associate

Worked as a Graduate Research Associate at University of Maryland.

. Using CFD methods, modeled and simulated packed bed and fluidized bed

reactors

. Studied the surface immobilization of enzymes in a fluidized bed

reactor

. Modeled chromatographic column as a packed bed reactor.

Scholastic Achievements

. Placed in top 2% of IIT engineering entrance examination in India

. One of the few selected students whose education was sponsored by

Ministry of Human Resource Development, India

. Represented Andhra Pradesh state in Indian National Mathematical

Olympiad

EDUCATION

MS Chemical Engineering

University of Maryland, USA, GPA: 3.7, 2007

BS Chemical Engineering

National Institute of Technology, India, GPA: 3.8, 2005

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