Sr. Cleaning Validation Engineer II

Initial Therapeutics, Inc.; Lexington (MA); On-site; USD 130,000 - 211,000; Full time

Job summary

A leading company is seeking a Sr. Cleaning Validation Engineer II to manage and develop validation programs in compliance with GMP regulations. This role involves creating and maintaining vital documentation, troubleshooting issues, and collaborating with various stakeholders. Ideal candidates should possess a Bachelor's degree and significant experience in cleaning validation activities.

Qualifications

• Bachelor’s degree in relevant field with 7 years of experience.
• Experience developing and executing Cleaning Validation protocols.
• Familiarity with GMP compliance and related regulations.

Responsibilities

• Manage validation programs and develop strategies for compliance.
• Create and maintain validation life cycle documentation.
• Troubleshoot cleaning and steam sterilization issues.

Skills

Validation programs management

Troubleshooting

Collaboration

Education

Bachelor’s degree in Industrial Chemical Engineering

Bachelor’s degree in Chemical Engineering

Bachelor’s degree in related field

Tools

IQ/OQ/PQ protocols

Risk assessments

Job description

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Job Description

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: 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 Corrective and preventive actions (CAPA’s), 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 executed 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

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.

LocationsLexington, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time