BioSpace is hiring: Sr. Cleaning Validation Engineer II in Lexington

Overview

JOB LOCATION: Lexington, MA

POSITION: Sr. Cleaning Validation Engineer II

POSITION DESCRIPTION: Shire Human Genetic Therapies, Inc. is seeking a Sr. Cleaning Validation Engineer II with the following duties:

• manage validation programs and projects.
• Develop validation strategies to test equipment and processes in compliance with domestic and international GMP regulations.
• Create and maintain validation life cycle documentation, including IQ/OQ/PQ protocols and reports, risk assessments, and traceability matrix.
• Provide technical assessments for CAPAs, deviation, and change control management.
• Troubleshoot cleaning and steam sterilization issues to ensure smooth manufacturing operation.
• Collaborate with stakeholders to establish project timelines and scopes.
• Review and approve validation deliverables including project plans, protocols, reports, risk assessments, and test scripts.
• Lead continuous improvements into validation activities and policies.
• Implement best practices for validation programs across facilities.
• Support new product rollout by validating new systems and processes during Tech Transfer.
• Represent the organization in contractual or project matters, interacting with senior internal and external personnel.
• Provide validation expertise to regulatory affairs when responding to governmental regulatory bodies.
• Up to 5% domestic travel required. Up to 40% remote work allowed.

REQUIREMENTS

• Bachelor’s degree in Industrial Chemical Engineering, Chemical Engineering, or related field, plus 7 years of related experience.
• Prior experience must include: prepare cleaning validation plan aligned with organization policy; prepare cleaning risk assessment for new product introduction or existing product introduced to a new system based on toxicology data; develop and execute Cleaning Validation (CV) testing Protocols to validate cleaning processes (Clean in Place (CIP), Clean Out of Place (Parts Washers) (COP)); develop and execute IQ/OQ/PQ protocols to qualify sterilization systems (autoclaves and Steam in Place SIP) and other GMP equipment.

Full time. $130,800 to $210,600 per year. Competitive compensation and benefits.

Qualified applicants can apply at https://jobs.takeda.com. Please reference job #R0152703. EOE

Locations: Lexington, MA

Worker Type: Employee

Worker Sub-Type: Regular

Time Type: Full time