Manufacturing Engineer

JIGAR PRAMOD VORA

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

Phone: 951-***-****

E-mail: ***********@*****.***

EXPERIENCE

ALLERGAN, Inc.

Irvine, CA

Feb. 2011 - Nov. 2014 Manufacturing Supervisor

> Managed 6 direct reports and indirect reports, including supervision

during production for processes involving cell culture, fermentation,

chromatography, ultrafiltration/diafiltration, centrifugation, sterile

filtration and aseptic filling of drug substance in a GMP environment.

> Participated in execution of FATs, SATs and commissioning for equipment

such as isolator, UF/DF skids, chromatography skids, fermenter and CIP

skids.

> Generated study protocols and reports associated with validation.

> Performed IOQ and PQ of process equipment such as autoclaves,

glasswasher, isolators, chromatography skids, fermenter, UF/DF skids,

biological safety cabinets (BSCs) and filling machines.

> Generated documents such as URS, SRA, and performing periodic review of

validation documents for manufacturing systems.

> Reviewed and approved validation reports and associated deviations.

> Conducted deviation, EM excursion, OOS/OOT and product impact

investigations, CAPA and change management using tools such as 5-Why

Analysis, Investigation Checklist, Ishikawa (Fishbone) Diagram.

> Tracked deviations, CAPAs and change controls within Trackwise.

> Coached manufacturing personnel in writing change controls, deviations

and conducting investigations.

> Trained and qualified manufacturing personnel on manufacturing

procedures and practices.

> Batch record and SOP creation/revision and approval as part of tech

transfer of new processes from R&D.

> Reviewed quality and engineering SOPs.

> Conducted cross-functional internal audits and participate in WWQA and

external audit from IMB.

> Supported compliance activities such as supplier qualification and

material qualification.

> Participated in continuous improvement processes using project

management tools such as project charters, RACI, Kaizen, Lean

Manufacturing and Value Stream Mapping.

Dec. 2006 - Feb. 2011 Senior Manufacturing Associate

Jun. 2004 - Dec. 2006 Manufacturing Associate

> Led manufacturing personnel in supporting tech transfer of new processes

from R&D.

> Conducted batch record and SOP generation/review as part of tech

transfer and periodic review.

> Performed purification processes such as chromatography,

ultrafiltration/diafiltration, centrifugation, sterile filtration and

aseptic filling.

> Supported validation in generating study protocols, validation

execution, generating URS and performing periodic review of validation

documents for manufacturing systems.

> Conducted cross-functional internal audits and participated in mock

external audits and WWQA audits.

> Participated in execution of FATs for equipment such as

ultrafiltration/diafiltration skid.

> Participated in deviations, EM excursion, OOT and product impact

investigations, CAPA and change management using tools such as 5-Why

Analysis, Investigation Checklist and Ishikawa (Fishbone) Diagram.

> Participated in continuous improvement processes using project

management tools such as project charters, RACI, Kaizen, 5S and Value

Stream Mapping.

Sep. 2002 - Jun. 2004 Senior Bioprocess Associate, Purification

> Conducted protein purification in R&D environment using processes such

as Ultrafiltration/Diafiltration, Centrifugation and Chromatography.

> Performed assays such as SDS-PAGE, ELISA, BCA protein quantitation

assay and UV Spectroscopy.

> Participated in execution of FATs for equipment such as autoclaves and

isolators.

Focus Technologies, Inc.

Cypress, CA

Aug. 2000 - Sep. 2001 Quality Control Lab Technician

> Conducted numerous assays such as IFA, ELISA, and Western Blot to test

and troubleshoot diagnostic kits and kit components for various

infectious diseases such as Herpes, Lyme Disease, and Dengue Fever.

EDUCATION

2000 - 2001 University of California, Riverside

Riverside, CA

M.S., Biochemistry and Molecular Biology

1996 - 2000 University of Southern California

Los Angeles, CA

B.S., Biomedical/Biochemical Engineering

ADDITIONAL INFORMATION

Skills

> Windows, MS-Word, MS-Excel, MS-PowerPoint, MS-Project, Visio, SAP,

Proficy IFix, Historian, Trackwise, Plateau LMS, Audit Utopia

> Extensive Experience with equipment FAT, SAT, commissioning, validation

and document generation and review (study protocols/reports, SOPs,

manufacturing batch records, validation protocols, reports, risk

assessments, URS).

> Experience in working in ISO8 and ISO7 cleanrooms and ISO5 aseptic

practices, fermentation, ultrafiltration/diafiltration and

chromatography processes

> Experience working under cGMP regulated environment, including ICH, EU

Annex 11 and 21 CFR Part 11 regulatory requirements.

Memberships/Association

> Parenteral Drug Association (PDA)

> International Society for Pharmaceutical Engineering (ISPE)

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