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Validation Engineer Senior

Company: Infotree Service Inc
Location: hopkinton
Posted on: May 3, 2021

Job Description:

Company DescriptionBio- PharmaJob DescriptionIdeal candidate- minimum of 5 years industry experience. Must have drug substance and/or drug product experience. Knowledge of steaming and cleaning cycle design concepts. Understanding of the allowable carryover calculations and their scientific basis. Proficiency in interpreting automation & Engineering documents and using PPrimarily responsible for ensuring adherence to equipment validation standards and procedures . Responsibilities include cleaning and steam validation strategy for new product introduction and/or equipment modifications; Validation of new MFG benchtop equipment; participation in system design; preparation of test protocols; analysis of test results and preparation of summaries/reports. Provides guidance and sets standards in producing quality documentation, serves as the liaison between the MFG/Engineering and Quality functions, provides testing and compliance guidance, and provides timely and effective response and follow-through in the resolution of Quality/Project compliance issues.QualificationsTop 3 Must Have Skill Sets: Knowledge of steaming and cleaning cycle design concepts Understanding of the allowable carryover calculations and their scientific basis Proficiency in interpreting automation & Engineering documents and using PAdditional InformationDay to Day Responsibilities: Write validation plans, execute validation Performance Qualifications Maintain the site cleaning acceptance criteria- Calculate the maximum allowable carryover (MAC) Oversee equipment validation, verification, equipment release and cleaning monitoring programs- Execution support for these activities, own SOPs and write the PQs and reports Consult on equipment validation impact for project planning-Understanding of the drug substance production process- Understanding of the worst case cleaning and steaming paths for each equipment type Knowledge of steaming and cleaning cycle design concepts-Understand the CIP and SIP automated cycles Communication across functional areasJob Location

Keywords: Infotree Service Inc, Warwick , Validation Engineer Senior, Other , hopkinton, Rhode Island

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