Validation engineer

Jaimin Patel

**** *********** **. **************, **-18031. 859-***-**** ******.*****@*****.***

Objective

Actively looking for a challenging position in the field of Pharmaceutical/Biotech Validation, Quaification, Process optimization, Quality improvement and process control etc.

Skills & Abilities

cGMP, GLP, Aseptic & Supervisory Experience, IQ, OQ, PQ, Validation, SOP writing, Protocol and Report writing, CAPA, Lean Six Sigma trained, Gage R&R, FMEA, HPLC, TOC, EDMS, MS Office, Minitab 16.

Experience

Sr. Validation Engineer – AstraZeneca for Maetrics

Feb ’18 – Present.

Compiled test and experimental data and performed appropriate analysis. Supplied quality assurance with necessary data required for regulatory submissions.

Perform investigations required for the completion of project deliverables.

Review, revise and maintain validation documentation including compiling data packs for all validation works.

Responsible for cleaning validation testing including visual inspection, and the collection of swab samples, and/or extraction samples.

Validation Specialist – Sanofi Pasteur for AumVis Pharmatec LLC.

Nov ’15 – Dec ’17

Responsible for generating development/validation protocols and reports.

Compiling data packs and analyzing data for adherence to established acceptance criteria.

Studies supporting the mixing, filling, filtration, lyophilizer, and inspection processes include hold time, CCIT, stability and extractables / leachables.

Supported executions of the OQ, PQ, and Process Validations.

Knowledge in vial and/or syringe filling equipment sufficient to identify process CPP’s and generating detailed validation protocol requirements and execution.

Validation Engineer – Bristol Myers Squibb for GR Validation.

Jul ’15 – Nov ‘15

Perform cleaning cycle development Trial and qualifications for a variety of equipment including: Process Vessels, bioreactors.

Perform cleaning validation testing including visual inspection, and the collection of rinse water samples, swab samples, and/or extraction samples.

Write and execute cycle development protocols including development of final reports.

Perform Out-of-Specification (OOS) Investigation, CAPA and writing OOS reports.

Review, revise and maintain validation SOP’s for conducting all validation works.

Perform batch record review, including verifying calibration and in-process data.

Perform spray coverage testing, cleaning verification swabbing

Process Technician – Sanofi Pasteur.

Mar ’14 – Jul ‘15

Responsible for sterilization, assembling and processing of supplies and equipment used in aseptic Downstream Manufacturing.

Monitoring and documenting process of Harvest, Inactivation, Filtration and Ultrafiltration.

Responsible for running, monitoring and documenting the process of CIP/Skid system, Tangentail Filteration Flow (TFF), UF/DF Skid, Filter Integrity Testing, Sonicater, parts washer.

Collecting samples at regular intervals during the processing stage and documenting all required data in Batch Production Record and LIMS Labware and also to track the status of the samples.

Troubleshooting of CIP/Skid system, Sonicator, Parts Washer and Filter Integrity Testing when needed.

Assisted Validation team in conducting validation testing for process and cleaning improvements.

Research Assistant/Validation Engineer – SPRC (Stevens Institute of Technology).

Sep ’12 – Nov ‘13

Collected Rinse and Swab samples and analyzed using TOC analyzer for Cleaning Validation studies.

Monitor CIP system and perform recovery studies to develop cleaning validation method using TOC analyzer.

Determining the Cleanability Index of Liquid and semi-solid dosage form using Gauge R&R tool for Cleaning Validation Study.

Planning, formulating, carrying out and supervising process trials in laboratories.

Reading and writing technical reports and specifications, and maintaining appropriate records, lab notebooks

Pharmacy Technician – Buffalo Pharmacies.

Jun ’11 – Jul ‘12

Preparing patient’s prescriptions according to the dosages filled by Pharmacists.

Preparation of IV’s according to the formulation prescribed by Pharmacists.

Worked as a Lead Technician during evening shifts.

Education

Stevens Institute of Technology – Hoboken, NJ. (Dec ’13)

Master of Science in Pharmaceutical Manufacturing.

State University of New York at Buffalo – Buffalo, NY. (Jun ’11)

Bachelor of Science in Medicinal Chemistry.

Bachelor of Arts in Chemistry.

Sri Sai College of Pharmacy – Bengaluru, India. (May ’06)

Diploma in Pharmacy.

Leadership

Stevens Pharmaceutical Research Center Club (SPRC) – President, Stevens Institute of Technology.

Campus Dinning and Shops – Student Manager, University at Buffalo.

Professional Training

“Six Sigma Green Belt Training” by Prof. Andrew Walsh, Stevens Institute of Technology, May 2013.

Contact this candidate