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Jr Validation Engineer Resume

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New Jersy, NJ

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OBJECTIVE: Seeking to obtain a dynamic and challenging position in the field of validation, safety, manufacturing,
quality or regulatory affairs.

SUMMARY: M.S in Pharmaceutical Manufacturing having two plus years of pharmaceutical industry experience
in the field of safety and validation.

  • Self-driven, result oriented individual with multidisciplinary and cross-functional experience having proficiency in pharmaceutical and computer system validation, safety, health and environment.
  • Extensive knowledge of compliance to FDA CFR Title 21 part 11, GMP, GCP, FAT
  • Proficient in validation requirements, Practice and procedure with risk assessment approach and cleaning validation, detail knowledge of equipment and process validation issues.
  • Strong exposure to environment related pharmaceutical issues and successfully solved them.
  • Experienced in air monitoring and noise monitoring within manufacturing area
  • Successfully worked with sustainability team to follow Lean six sigma manufacturing.

WORK
EXPERIENCE: Confidential,NJ – Jr. Validation Engineer Jan 09 to Present
Responsibilities:

  • Developing IQ, OQ and PQ protocols for equipments (mixer, control valve, dryer, compression press) reviewing and executing them
  • writing functional tests, Conducting design experiments, content uniformity tests, cleaning validation, validation with change control and CAPA
  • Developing deviation reports and commissioning
  • Executing process validation, developing SOPs
  • Successfully initiated paperless documentation system with FDA CFR 21 Part 11 compliance.

Confidential,DE – SHE Intern May 08 to Dec 09
Responsibilities:

  • Conducted IH monitoring for site (air and noise), assisted with monitoring plan review to achieve the goals.
  • Successfully supported Sustainability team and partners with energy calculation to follow Lean manufacturing.
  • CO2 emission
  • Water/wastewater metering
  • Quarterly results
  • Prepared and presented required safety training packages to operators and contractors, performed PPE Assessment.
  • Built key relationships with SHE customers (SE&M,Mfg,Pkg)


Confidential,, India - Assistant May 07 to Aug 07
Responsibilities:

      • Maintained the tablet coating of all tablet batches
      • Documented the data of batch to batch tablet coating, thickness and uniformity

Confidential,India – Trainee Jan 07 to April 07
Responsibilities:

  • Handled tablet and parental production in the supervision of production manager

COMPUTER Operating Systems: Windows XP, Macintosh, Windows Vista
SKILLS: Software: Microsoft Word, Excel, PowerPoint, Outlook, Adobe Photoshop
7.0, Adobe premiere 7.0, Microsoft project, Minitab 15, CorelDraw, M-files

EDUCATION: MBA in Pharmaceutical Management
M.S. in Pharmaceutical Manufacturing
Bachelor of Pharmacy

CERTIFICATION: Validation and Regulatory Affairs
Stevens Institute of Technology in 2009

PROJECT: Document Management System Research Project: Present
WORK Confidential,NJ, USA - Under Prof, Andrew Walsh

      • Working on developing new electronic document management system called M-files, learning it to use and install on the Stevens server and managing the technical aspects.
      • Plan to launch this system first in the Stevens Academic projects and then to the Industries through my guide.

Statistical Evaluation of Cancer Therapies: 2006 AND 2007
Confidential,India – Under Prof. Ashutosh Jani

      • Statistically evaluated two therapies (Chemotherapy and radiotherapy) of cancer with 300 cancer patients of Civil Hospital using S-36 form.
      • Presented the Research paper in Annual State Academic Projects in 2007.

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