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.



Locations
USA - MA - Lexington - BIO OPS

Worker Type
Employee

Worker Sub-Type
Regular

Time Type
Full time