#hiring *Validation Maintenance Manager (Hybrid)*, Boston, *United States*, $171K, fulltime #opentowork #jobs #jobseekers #careers $171K #Bostonjobs #Massachusettsjobs #TradesServices
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By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Job Title: Validation Maintenance Manager Location: Lexington, MA About the role: As the Validation Maintenance Manager, you will provide leadership to the Validation Maintenance Program for annual requalification of GxP manufacturing equipment used for commercial production, including developing validation strategy to the site and global projects. You will have engineering validation oversight and engineering validation signatory responsibility for approval of commissioning, qualification / validation, and final report documents. You will report to the Engineering Services Lead. How you will contribute: Assess, qualify and validate equipment, critical systems (utilities), facilities, computerized systems, cleaning and sterilization processes. Coordinate with manufacturing and production schedules to access equipment to perform requalification on performance, cleaning or periodic reviews. Improve and adapt the Validation Maintenance Program processes to meet demands in the manufacturing facility by building partnerships across departments. Lead and represent the respective validation elements to determine validation strategy and system validation requirements based on concepts of life cycle to meet regulatory guidelines and industry standards. Develop protocols, coordination of validation activities, qualification/validation execution, preparing final reports and assembly of final validation packages; generation of project plans consisting of both initial validation efforts and revalidation. Write protocols and reports, and interpret validation documents regarding acceptability to industry standards (GMPs, FDA Guidelines), procedures, and regulatory requirements such as (21 CFR Parts 210, 211, 600, ISO 14644, EC-Annex1). Plan, and schedule validation assignments and lead the validation team to prepare protocols and material for each activity. Guide peers in Validation and Engineering Departments to use statistically based Quality Engineering approaches in project, test plans and in analysis of test results. Review change control requests with potential impact to validated state of validation elements, as applicable. Utilize Quality-Engineering tools to problem solve/troubleshoot and assist in risk analysis (e.g., FMEA, Design of Experiments, QbD, SPC). Identify gaps related to validation requirem
