Senior Cleaning Validation Engineer (Boston, MA)
Validation Technologies, Inc - Boston, MA

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Location: Greater Boston, MA

Outstanding opportunity to join and drive our high performing and talented team comprised of exceptional validation professionals within their field! Validation Technologies, Inc. (VTI) is currently looking to identify a Senior-Level Cleaning Validation Engineer/Specialist to complete our Biopharma “dream team,” in the northeast region.

Acting as the "go to" Cleaning Validation guru for VTI, the Senior Validation Professional will be in a highly visible and critical role within our global organization.

VTI offers competitive compensation, excellent benefits, 401K plus a stimulating and collaborative work environment.

Validation Technologies, Inc. (VTI) strives to maintain and inspire professional excellence by providing Commissioning, Qualification and Validation Services to the Pharmaceutical, Biotech, Biologics and Medical Devices Industries. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.

Responsibilities:

In This Position, You Will:
  • 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) and operational qualification (OQ) related to IOQ equipment and support cleaning validation/ cleaning verification activities related to the purification process (i.e. Chromatography Skids; UF/DF Skids; Buffer; Tanks, etc.)
  • Perform regular clean in place/clean out of place and steam in place/steam out of place (CIP/SIP).
  • 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 cleaning validation/verification protocols, technical documents, IOQ protocols and final reports

Qualifications:
  • Over 4+ years of Validation and Qualification experience in Biotech/Biologics/Pharma industries
  • Bachelor’s degree or higher in Engineering, Life Sciences or related discipline (Engineering, ChemEng, Chemistry, Biology, etc.)
  • Hands-on experience supporting/executing IQ, OQ (IOQ) equipment qualification related to various cleaning processes and activities (i.e. UF/DF skids, tanks, buffers, lyophilizers, etc.)
  • Thorough knowledge of cGMP/FDA regulations and clean room environment
  • Demonstrated understanding reviewing/writing technical documents, risk assessment reports, validation documents, IOQ 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

Validation Technologies Offers:

As one of the leading global Commissioning, Qualification 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.

Validation Technologies, Inc - 16 months ago - save job - block