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Validation Specialist V

VTI Life Sciences is a highly successful, growing Biopharmaceutical consulting company.  We are currently seeking a Project Scheduler for our client in the Greater Scranton, PA area to work with the client in generating development / validation protocols and reports, compiling data packs and analyzing data for adherence to established acceptance criteria. Typical processes being developed / validated include mixing, filling, formulation, filtration and shipping. Studies supporting these processes include hold time, CCIT, stability and extractables / leachables. 

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.

Experience Requirements:

  • Experience with cold chain management, including generation of validation protocols and reports, the management of shipping processes from shipping design to logistics.
  • Experience with the execution of shipping validation studies.   
  • Knowledge of shock and vibration, temperature distribution, CCIT, and Sterility assessments of shipping studies.  
  • Expertise with the shipment of in process and final containers.
  • Experience with ISTA (International Safe Transit Association)  FDA/EU, Cold Chain Management requirements.
  • Formulation process validation
  • Filling process validation
  • Aseptic Processing experience
  • Recent hands on experience executing   process validations
  • For filling, significant experience from production or engineering assignments to have in-depth knowledge of vial and/or syringe filling equipment sufficient to identify process CPP’s and generate detailed  validation protocol requirements and execution
  • For formulation demonstrated experience with mixing and filtration process validation.
  • Experience:5 to 7 years.  Experience in Process Validation (formulation and/or filling), Performance Qualification, E&L, CCIT, shipping validation, and/or Filter Validation.  International shipping experience is a plus.

Skills:

  • Skills, MS Office 2010, E Doc, Pharmaceutical Validation, Bio Pharma Validation, Validation execution,
  • Technical writing abilities and good time management.  Strong root cause analysis skills with cGMP experience.  To be able to establish working relationships with other support and production areas in order to gather all of the necessary information required.
  • Must be proficient in E Doc with a working knowledge of templates, workflows and approval process Proficient in MS Word, Excel, Powerpoint and Outlook Interact well with a diverse group of individuals Self motivated and willing to be pro active in resolving issues
  • Excellent Verbal and written communication skills.   Ability to work in a team environment.

Education:

  • BS/MS in Engineering, Life Science or Physical Science

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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