JobsUSASr. Cleaning Validation Engineer II
Company : BioSpace, Inc.
Location : Lexington, MA, 02173
Posted Date : 15 September 2025
Job Type : Other
Category : Mechanical Engineering
Occupation : Validation Engineer
Job Details
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Job Description
Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Shire Human Genetic Therapies, Inc. for the following job opportunity:
JOB LOCATION: Lexington, MA
POSITION : Sr. Cleaning Validation Engineer II
POSITION DESCRIPTION : Shire Human Genetic Therapies, Inc. is seeking a Sr. Cleaning Validation Engineer II with the following duties: manage validation programs and projects. Develop validation strategies to test equipment and processes in compliance with domestic and international GMP regulations. Create and maintain validation life cycle documentation, including IQ/OQ/PQ protocols and reports, risk assessments, and traceability matrix. Provide technical assessments for Corrective and preventive actions (CAPA's), deviation, and change control management. Troubleshoot cleaning and steam sterilization issues to ensure smooth manufacturing operation. Collaborate with stakeholders to establish project timelines and scopes. Review and approve validation deliverables including project plans, protocols, reports, risk assessments, and test scripts. Lead continuous improvements into validation activities and policies. Implement best practices for validation programs across facilities. Support new product rollout by validating new systems and processes during Tech
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