Senior Validation Engineer I

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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: Senior Validation Engineer I

POSITION DESCRIPTION: Shire Human Genetic Therapies, Inc. is seeking a Senior Validation Engineer I with the following duties: Perform for a majority of validation programs of the site, including Facilities, Utilities & Equipment (FEU), Cleaning (CIP/COP), Sterilization (Autoclaves & SIPs), Computer System Validation, Analytical Instrument Qualification, Chambers, Warehouses & Shipping, & Validation Maintenance. Collaborate with cross-functional project team members (OpEx or CapEx Projects) to participate in validation strategy discussion & system validation requirements based on concepts of life cycle: user requirements, functional specifications, design specifications, commissioning & validation. Perform Project Management activities (resource loading, communication strategies, & escalation). Monitor & track progress & effectively communicate project status to peers, project stakeholders, & department leaders. Collaborate with other validation department FTEs & contractors to ensure project deliverables are met & allocate resources based on project demands. Manage proposals including budgetary & schedule estimates from vendors for project scopes, timesheets & resource forecast. Develop protocols, coordinate validation activities, qualify/validate execution, prepare final reports & assemble final validation packages for qualification activities. Generate protocols & reports, execute & evaluate validation documents for acceptability to industry standards (GMPs, FDA Guidelines), procedures, & regulatory including 21 CFR Part 210, 211, 600, ISO 14644, EC-Annex1. Perform requalification (Validation Maintenance) activities including CIP/COP, chamber. Perform reviews/approvals of protocols & final reports for both standard & complex projects for other Department members. Author deviations/discrepancies & updates to site validation plans & manage/track progress for annual execution schedules & author & review responses to inspection observations & agency questions. Up to 20% remote work allowed.

Estimated salary range reflects expected pay for this role. Actual base salary depends on the applicant’s qualifications, experience, skills, education, certifications, & work location, & will comply with all applicable minimum‑wage laws. U.S. employees may be eligible for medical, dental, & vision insurance, 401(k), paid time off, sick leave, company holidays, incentive compensation programs, & other benefits offered under company policies.

REQUIREMENTS: Bachelor’s degree in Mechanical Engineering or related field plus 30 months of related experience. Prior experience must include: develop and execute qualification protocols and reports for facilities, utilities, equipment, cleaning, and sterilization systems in compliance with 21 CFR 210/211; perform commissioning and qualification (IQ/OQ/PQ) of manufacturing systems including automation platforms and analytical instruments; manage validation projects including resource planning, tracking progress, and communicating status to cross-functional stakeholders; investigate deviations and implement CAPA while identifying validation compliance gaps against GMP and ISO 14644 standards; perform equipment qualification (IQ/OQ/PQ) and requalification for CIP/COP, autoclaves, SIP, and chambers.

Full time. $104,541 to $141,240 per year.

Qualified applicants can apply at https://jobs.takeda.com. Please reference job #R0189479. EOE

Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue, NW, Room N-5311, Washington, DC 20210.

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