BioSpace, Inc.
Sr. Cleaning Validation Engineer II
BioSpace, Inc., Lexington, Massachusetts, United States, 02173
Job Details
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.
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.
Locations Lexington, MA
Worker Type Employee
Worker Sub-Type Regular
Time Type Full time
Company
For over 240 years, Takeda's propensity to evolve has driven the next generation of innovation. Today, our organization spans the globe-colleagues across business units and functions face challenges head-on to deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.
As a values-based, R&D-driven biopharmaceutical leader headquartered in Japan, we focus our R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. In addition to our R&D efforts, we're laser-focused on harnessing the power of data, digital, and technology to improve health outcomes for patients across the globe.
Since our founding in Japan, integrity and putting patients first have been at the heart of our identity. We're proud of our employees and their commitment to improving the quality of life for patients, and to working with our partners in health care in approximately 80 countries and regions. With each new breakthrough comes opportunities to develop your career, hone new skills, and create a brighter future
For more information, visit https://jobs.takeda.com/
Company info Website https://www.takeda.com/ Location 650 East Kendall Street Cambridge MA 02421 United States
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By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.
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.
Locations Lexington, MA
Worker Type Employee
Worker Sub-Type Regular
Time Type Full time
Company
For over 240 years, Takeda's propensity to evolve has driven the next generation of innovation. Today, our organization spans the globe-colleagues across business units and functions face challenges head-on to deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.
As a values-based, R&D-driven biopharmaceutical leader headquartered in Japan, we focus our R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. In addition to our R&D efforts, we're laser-focused on harnessing the power of data, digital, and technology to improve health outcomes for patients across the globe.
Since our founding in Japan, integrity and putting patients first have been at the heart of our identity. We're proud of our employees and their commitment to improving the quality of life for patients, and to working with our partners in health care in approximately 80 countries and regions. With each new breakthrough comes opportunities to develop your career, hone new skills, and create a brighter future
For more information, visit https://jobs.takeda.com/
Company info Website https://www.takeda.com/ Location 650 East Kendall Street Cambridge MA 02421 United States
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