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Validation Engineer III

VTI Life Sciences is a highly successful, growing Biopharmaceutical consulting company.  We are currently seeking a Validation Engineer III with cleaning and equipment validation experience to perform instrument qualification with our client in the Boston, MA area.

VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics, Medical Devices and Lifesciences industries. VTI Life Sciences offers professional development, training, 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.


Duties:

Employ in-depth technical knowledge in the field of analytical experiment design and execution often working independently to design and implement a series of experiments. A successful candidate must have strong organization skills and ability to write technical reports describing the experiments and their outcome. Experience in separation of biomolecules is a plus. Must be well-versed in the software and hardware for Seevers TOC, Waters HPLC and other laboratory instrumentation. Experience with TOC and cleaning validation is highly desired.  Experience of working in a GMP regulated environment is a must. Experience with data bases is a plus.
 

Experience:

3 to 6 years.

Skills: 
Instrument qualification including TOC, HPLC, plate readers and other laboratory equipment for a GMP laboratory operation.
Development and validation of analytical methodologies especially TOC methods related to cleaning validation/verification of manufacturing equipment in the manufacturing process.
Conduct TOC and other analytical testing in the QC laboratory under GMP conditions..
Support analytical activities related to computer system remediation's in the QC laboratories.
Mentor laboratory personnel in methods related to cleaning validation/verification

Education: 
Instrument qualification including TOC, HPLC, plate readers and other laboratory equipment for a GMP laboratory operation.
Development and validation of analytical methodologies especially TOC methods related to cleaning validation/verification of manufacturing equipment in the manufacturing process.
Conduct TOC and other analytical testing in the QC laboratory under GMP conditions..
Support analytical activities related to computer system remediation's in the QC laboratories.
Mentor laboratory personnel in methods related to cleaning validation/verification
Skills and Experience:

Required Skills:  

  • GMP
  • HPLC
  • INSTRUMENTATION
  • LABORATORY
  • LABORATORY EQUIPMENT  
  • Additional Skills:
  • MANUFACTURING PROCESS
  • MEDICAL DEVICE
  • ORGANIZATION SKILLS
  • SOPS
  • WATERS HPLC
  • WRITING SKILLS
  • ANALYTICAL TESTING
  • CGMP
  • CHEMISTRY
  • EQUIPMENT SALES
  • INORGANIC CHEMISTRY
  • MENTOR
  • REMEDIATION
  • TESTING  

Languages:
English
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VTI Life Sciences Offers:

As one of the leading global Commissioning, Qualification and Validation Services organizations, VTI Life Sciences 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.  www.validation.org

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