JVT Advisors

Validation Engineer- SME

Apply Now

Location: Waltham, Massachusetts 02452
Employment Type: Contract

Job Description

Contract Length:  3+ months


Job Summary:  The Validation Engineer will be responsible for a myriad of tasks involved in starting equipment and utilities including protocol generation, and execution of Validation protocols including Vial filling, lyophilization, and sterilization application.



  • Perform validation activities on utilities and manufacturing process equipment and instruments.
  • Prepare/Update Validation Master Plans, Project Plans, and Protocols; CQV Plans
  • Performs testing, collects samples, analyze test results, and prepare validation and Qualification summary reports.
  • Prepare system turnover packages in accordance with project procedures by assembling and reviewing all system test documentation (all disciplines) for adequacy and completeness.
  • Create and execute commissioning and qualification protocols/test plans for facilities, utilities and equipment using a risk-based approach.
  • Author, review and execute validation protocols, reports, product impact assessments for vial filling, lyophilization and support utilities.



  • BS in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology. • 10+ years of experience in validation within the pharmaceutical/biotechnology industry or MS in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology.
  • Experience in aseptic fill/finish unit operations (Vial washing, freeze/thaw, mixing, sterile filtration, filling, stoppering, lyophilization, etc.) to define critical process parameters  
  • Aseptic fill finish manufacturing or manufacturing technical services experience  
  • Understanding of process related stresses that impact the quality and stability of biologics
  • Fill/finish process validation and technology transfer experience including the use of gap analysis, root cause analysis, and risk assessment tools.



Can't find your fit?

We get new jobs every day. Send us your resume and we'll let you know when we have the right opportunity for you.

Send Us Your Resume