Senior Validation Engineer I

3383 Shire Human Genetic Therapies•Lexington, MA

1d•Hybrid

About The Position

Shire Human Genetic Therapies, Inc. is seeking a Senior Validation Engineer I. This role involves performing validation for a majority of the site's validation programs, including Facilities, Utilities & Equipment (FEU), Cleaning (CIP/COP), Sterilization (Autoclaves & SIPs), Computer System Validation, Analytical Instrument Qualification, Chambers, Warehouses & Shipping, & Validation Maintenance. The engineer will collaborate with cross-functional project team members on validation strategy and system validation requirements, manage project activities, monitor progress, and communicate status. They will also manage vendor proposals, develop protocols, coordinate validation activities, prepare final reports, and assemble validation packages. The role requires generating and evaluating validation documents against industry standards (GMPs, FDA Guidelines), procedures, and regulations such as 21 CFR Part 210, 211, 600, ISO 14644, and EC-Annex1. Additionally, the engineer will perform requalification activities, review and approve protocols and reports for other team members, author deviations and updates to site validation plans, and respond to inspection observations and agency questions. Up to 20% remote work is allowed.

Requirements

Bachelor’s degree in Mechanical Engineering or related field
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

Responsibilities

Perform validation for a majority of the site's validation programs, 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.