Senior Validation Engineer I

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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 PartISO 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 applicants qualifications experience skills education certifications & work location & will comply with all applicable minimumwage 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: Bachelors 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. $104541 to $141240 per year.

Qualified applicants can apply at . 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.