[Hiring] Senior Validation Engineer I @Takeda

Role Description

Shire Human Genetic Therapies, Inc. is seeking a Senior Validation Engineer I with the following duties:

• Perform 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.

Qualifications

• Bachelor’s degree in Mechanical Engineering or related field.
• 30 months of related experience.

Requirements

• 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.

Benefits

• Medical, dental, & vision insurance.
• 401(k).
• Paid time off.
• Sick leave.
• Company holidays.
• Incentive compensation programs.
• Other benefits offered under company policies.