Validation Engineer- SMEApply Now
Location: Waltham, Massachusetts 02452
Employment Type: Contract
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.
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