Validation Engineer-Cleaning Validation-Sterilization Validation
Validation Technologies, Inc - United States

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Exceptional/immediate opportunity to join a dynamic team of technical experts. Validation Technologies, Inc. (VTI) is currently looking to identify several high caliber Cleaning Validation Engineers/Validation Specialists, as well as Project Manager (PM) to complete our team in the Los Angeles, San Francisco Bay Area, San Diego, Boston, Philadelphia, New Jersey and other parts of USA .

**Level/Title/Compensation of position contingent on experience and expertise**

VTI offers competitive compensation, excellent benefits, 401K plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.

Validation Technologies, Inc. strives to maintain and inspire professional excellence by providing Commissioning, Qualification, IT and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Devices Industries.

Responsibilities:

In This Position, You Will:

Cleaning Experience
  • Be in highly strategic role and have an exceptional opportunity to make an immediate and rewarding impact on our global organization!
  • Have proven track-record of successfully executing high-profile cleaning validation & equipment qualification projects
  • Join dynamic validation team responsible for the installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) related to supporting/executing various cleaning validation activities and process equipment (i.e. Chromatography Columns/Skids; MF Skids; Buffer; Tanks, etc.)
  • Perform regular Clean Out of Place (COP) related to parts washers, and Manual Cleaning etc.
  • Summarize and evaluate cleaning validation findings in a clear, orderly and succinct manner
  • Perform cleaning validation sampling using standard operating procedures (SOP)s to evaluate cleaning procedures
  • Write/execute cleaning validation protocols, technical documents and final report to support the validation performance qualification (PQ)
Sterilization Experience
  • Experience in writing, execution and summary reports for IQs/OQs and PQs for various GMP process equipment and utilities.
  • Perform regular Sterilization and SIP for various autoclave and process vessels, etc.
  • Must have understanding for load configuration Fos, BI and using the Kaye digi or other thermo mapping instruments
  • Write/execute cleaning validation protocols, technical documents and final report to support the validation performance qualification (PQ)
  • Summarize and evaluate sterilization validation findings in a clear, orderly and succinct manner
  • Write/execute sterilization validation protocols, technical documents and final report to support the validation performance qualification (PQ)

Qualifications:
  • Over 3+ years of Cleaning Validation and Sterilization experience in Pharmaceutical/Biotechnology/Biologics industries
  • Bachelor’s degree or higher in Life Sciences or related discipline (Engineering, ChemEng, Chemistry, Biology, etc.)
  • Hands-on experience supporting/executing IQ, OQ, PQ related to various cleaning processes and activities (i.e. reactors, chromatography columns/ skids, tanks, buffers, parts washers, etc.)
  • Thorough knowledge of cGMP/FDA regulations and clean room environment
  • Demonstrated understanding reviewing/writing technical documents, risk assessment reports, validation documents, IOQ/PQ protocols and final reports
  • Strong interpersonal skills, coupled with attention to detail, excellent review skills and analytical skills
  • Must have strong ability to organize and manage multiple tasks in a fast-paced environment
**Level/Title/Compensation of position contingent on experience and expertise**

Validation Technologies Offers:

As one of the leading global Commissioning, Qualification, IT and Validation Services organizations, VTI is always looking for innovative, talented and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees as well as competitive hourly pay for our contractors.