Manufacturing Process

CURRICULUM VITAE

Hrutvik J. Patel

**** ******* *****, ******, **. 07001 Cell: - 201-***-****, Email:- ************@*****.***

OBJECTIVE: Seeking a full time position as a Validation Specialist in Pharmaceutical/ Bio-

pharmaceutical industry.

PROFESSIONAL EXPERIENCE:

Validation Specialist,

(Hemispherx Biopharma, New Brunswick, NJ) March 12 – Present

• Draft Cleaning Assessment Protocols for Portable Equipment and Multi-Processing Units (MPUs)

• Draft qualification documents (IQ, OQ & PQ) and executed protocols for portable equipment (pump,

biological safety hood, various tanks) and Multi processing units like process chiller, air compressor

system, mille glass washer.

• Generate Standard Operating Procedures (SOPs), process development study protocols and

corresponding reports.

• Draft Qualification documents (IQ, OQ & PQ) for different temperature mapping equipment and

executed protocol for primus sterilizer, refrigerator, ultra-low freezer (-70 C), Incubator, cold box and

virtis benchmark freeze dryer using kaye validator.

• Analyze test data, investigate, Write deviation reports, trouble shoot as necessary, and write final

reports for validation study, also review of technical documentation for completeness.

• Write Cleaning Assessment Summary Reports on executed assessment protocols and compiling data

packages of executed protocols.

• Generate Cleaning Development Protocols for the Portable Equipment, and Spray Coverage Testing

Documentation.

• Active participation in core team meetings to define strategies & approach related to cleaning method

development and cleaning method validation.

• Review of SOPs, Protocols, Summary Reports and Deviation Reports before final approval

• Expert in root cause analysis techniques, cGMP documentation practice and expert in understanding

of change control process.

• Ability to read engineering drawings P&ID (Piping and installation diagram).

Filling & Formulation Operator, Manpower (Sanofi- Pasteur, Swiftwater, PA) Feb. 11 – Dec. 11

• Worked on INOVA Vial & Syringe Filler in a core area for Flu, Tetanus & Meningitis Vaccines (Sterile

Injectables)

• Hands on experience in RABS operation, troubleshooting, resolution in technical issues, routine & non-

routine interventions in the RABS

• Trainer for Aseptic Operator, RABS Gloves Testing and Aseptic Cleaning Technique

• Well experienced in Class A, B, C & D cleaning & disinfection, Palltronics & Millipore filter testing

• Qualified Environmental monitoring Operator for viable & nonviable particulate count, pressure &

temperature differential changes & Sterile room release for Grade A,B,C & D Areas

• Performed CIP (Clean in Place) and SIP (Sterilize in Place) on a routine and non-routine basis for

RABS also Trained on Requalification (yearly) of CIP and SIP

• Documentation of BFR (Batch Filling Records), SOP, CIP & SIP log, cleaning logs & logbook,

deviations, change control requests

• Active participation in development & validation studies for lyophilized product called C. Difficile

vaccine

Process Validation Project (Stevens Institute of Technology) Sep. 09 – Dec. 09

• Developed DOE for Blending and Cleaning Process by identifying critical operating parameters for the

same process

• Generated SOPs for operation & cleaning of various equipments and process, Training records for

SOPs, Laboratory Reports, FMEA, Validation Master Plan, Quality Policy, Calibration and Maintenance

Record, Quality Audit, Master batch record, Process Flow Diagram,

• Drafted IQ, OQ and PQ for blenders and laboratory parts washers

• Ran process validation batches to validate manufacturing process for cookies simulating tablet

manufacturing and to validate cleaning method for cleaning manufacturing equipment

• Derived results, graphs using statistical software Minitab and identified sources of variation by

interpreting graphs and results

• Having thorough idea of NDA & ANDA application procedure, also presented paper on NDA and ANDA

submission procedure, regulatory requirements for FDA & EU approval

SOFTWARE SKILLS:

Microsoft Office 2008 and 2010 (Word, Excel, PowerPoint), Microsoft Visio 2008 and 2010, Microsoft

Project 2007, Pharmaceutical Statistical Software-Minitab 15/16, LIMS

EDUCATION:

Master of Science in Pharmaceutical Manufacturing GPA: 3.833/4.0

Major: - Validation & Regulatory Affairs

Stevens Institute of Technology, Hoboken, NJ, USA

Coursework:

Validation and Regulatory Affairs in Pharmaceutical Manufacturing, Contemporary Concepts in Pharmaceutical

Validation, Design and Management of Sterile Pharmaceutical Manufacturing, Introduction to Project

Management, Regulation and Compliance in Pharmaceutical Industry, Computerized System Validation,

Pharmaceutical Finishing & Packaging System, Engineering Economics & Cost Analysis

Projects:

1. BOD A for Sterile Facility Sep. 10 – Dec. 10

• Presented three different site for manufacturing of new potential sterile blockbuster drug

• Generated User Requirement Specification Documentation (URS) and Functional Specification

Documentation (FS) to propose different technology

• Provided options for different technology that can be used for production and calculated capacity

analysis for each option

• Developed design for manufacturing area, flow of material, man and air throughout the facility

• Awarded best possible design for sterile facility among all proposed design

Bachelor of Science in Pharmaceutical Sciences GPA:

3.82/4.0

L.B.R.I.P.E.R (Gujarat University), khambhat, Gujarat, India

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