Validation Engineer - Process Validation
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Job Description
Shire Human Genetic Therapies, Inc. is seeking a Validation Engineer - Process Validation in Lexington, MA with the following requirements: Bachelor's degree in Chemical/Biochemical/Bioprocess Engineering, Chemistry, Biochemistry, or related field or foreign academic equivalent plus 5 years of related experience OR Master's degree in Chemical/Biochemical/Bioprocess Engineering, Chemistry, Biochemistry, or related field or foreign academic equivalent plus 3 years of related experience OR PhD degree in Chemical/Biochemical/Bioprocess Engineering, Chemistry, Biochemistry, or related field or foreign academic equivalent plus 0 years of related experience. Required skills: Working knowledge of the science and technology for the major unit operations associated with manufacturing operations; work with industry validation requirements and author and execute validation qualification protocols and reports; troubleshoot/problem-solve and risk assessment/mitigation; excellent written and verbal communication skills; able to work independently in a fast-paced environment and manage multiple projects and priorities. Up to 40% remote work allowed.
Apply on-line at and search for Req #R0115448.
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: Validation Engineer - Process Validation
POSITION DESCRIPTION: Shire Human Genetic Therapies, Inc. is seeking a Validation Engineer - Process Validation with the following duties: provide validation support for Shire biologics manufacturing operations located in Lexington and Cambridge; author validation protocols and other documentation for cell culture, purification, mixing, and chromatography/membrane lifetime processes; execute validation studies, as well as perform data analysis and compilation of data and results into summary and final reports; align manufacturing processes with executed validation; participate in regulatory inspections; identify opportunities for continuous improvements; participate in the deployment of best practices, represent validation at Lexington Site Work System meetings and support/maintain the validation communications board and community of practice; write, execute, analyze results, and summarize validation activities in the following areas: Tech transfer (new product introduction), change management, continuous lifecycle management, develop and assess the following Quality System elements for Validation: CAPAs, Deviations; participate and contribute in design, development validation, and routine GMP activities: provide technical input to validation activities, represent validation during tech transfer activities as required, represent validation during site GMP activities and participate on cross-functional teams, support validation Quality Systems; identify opportunities for personal and professional; development, continuous improvements, participate in the deployment of best practices, represent validation at Lexington Site Work System meetings and support/maintain the validation communications board; participate in regulatory agency inspections for Validation; train other Shire staff on validation protocols. Up to 40% remote work allowed.
REQUIREMENTS: Bachelor's degree in Chemical/Biochemical/Bioprocess Engineering, Chemistry, Biochemistry, or related field or foreign academic equivalent plus 5 years of related experience OR Master's degree in Chemical/Biochemical/Bioprocess Engineering, Chemistry, Biochemistry, or related field or foreign academic equivalent plus 3 years of related experience OR PhD degree in Chemical/Biochemical/Bioprocess Engineering, Chemistry, Biochemistry, or related field or foreign academic equivalent plus 0 years of related experience. Required skills: Working knowledge of the science and technology for the major unit operations associated with manufacturing operations; work with industry validation requirements and author and execute validation qualification protocols and reports; troubleshoot/problem-solve and risk assessment/mitigation; excellent written and verbal communication skills; able to work independently in a fast-paced environment and manage multiple projects and priorities. Up to 40% remote work allowed.
Full time. $130,106.00 - $152,200 .00 per year. Competitive compensation and benefits.
Qualified applicants can apply at Takeda careers page at: Please reference job #R0115448 . 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.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Lexington, MA
U.S. Base Salary Range:
Kristin Test
$0.00 - $0.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained , certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based e mployee s may be eligible for s hort - t erm and/ or l ong- t erm incentive s . U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
Lexington, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Description
Shire Human Genetic Therapies, Inc. is seeking a Validation Engineer - Process Validation in Lexington, MA with the following requirements: Bachelor's degree in Chemical/Biochemical/Bioprocess Engineering, Chemistry, Biochemistry, or related field or foreign academic equivalent plus 5 years of related experience OR Master's degree in Chemical/Biochemical/Bioprocess Engineering, Chemistry, Biochemistry, or related field or foreign academic equivalent plus 3 years of related experience OR PhD degree in Chemical/Biochemical/Bioprocess Engineering, Chemistry, Biochemistry, or related field or foreign academic equivalent plus 0 years of related experience. Required skills: Working knowledge of the science and technology for the major unit operations associated with manufacturing operations; work with industry validation requirements and author and execute validation qualification protocols and reports; troubleshoot/problem-solve and risk assessment/mitigation; excellent written and verbal communication skills; able to work independently in a fast-paced environment and manage multiple projects and priorities. Up to 40% remote work allowed.
Apply on-line at and search for Req #R0115448.
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: Validation Engineer - Process Validation
POSITION DESCRIPTION: Shire Human Genetic Therapies, Inc. is seeking a Validation Engineer - Process Validation with the following duties: provide validation support for Shire biologics manufacturing operations located in Lexington and Cambridge; author validation protocols and other documentation for cell culture, purification, mixing, and chromatography/membrane lifetime processes; execute validation studies, as well as perform data analysis and compilation of data and results into summary and final reports; align manufacturing processes with executed validation; participate in regulatory inspections; identify opportunities for continuous improvements; participate in the deployment of best practices, represent validation at Lexington Site Work System meetings and support/maintain the validation communications board and community of practice; write, execute, analyze results, and summarize validation activities in the following areas: Tech transfer (new product introduction), change management, continuous lifecycle management, develop and assess the following Quality System elements for Validation: CAPAs, Deviations; participate and contribute in design, development validation, and routine GMP activities: provide technical input to validation activities, represent validation during tech transfer activities as required, represent validation during site GMP activities and participate on cross-functional teams, support validation Quality Systems; identify opportunities for personal and professional; development, continuous improvements, participate in the deployment of best practices, represent validation at Lexington Site Work System meetings and support/maintain the validation communications board; participate in regulatory agency inspections for Validation; train other Shire staff on validation protocols. Up to 40% remote work allowed.
REQUIREMENTS: Bachelor's degree in Chemical/Biochemical/Bioprocess Engineering, Chemistry, Biochemistry, or related field or foreign academic equivalent plus 5 years of related experience OR Master's degree in Chemical/Biochemical/Bioprocess Engineering, Chemistry, Biochemistry, or related field or foreign academic equivalent plus 3 years of related experience OR PhD degree in Chemical/Biochemical/Bioprocess Engineering, Chemistry, Biochemistry, or related field or foreign academic equivalent plus 0 years of related experience. Required skills: Working knowledge of the science and technology for the major unit operations associated with manufacturing operations; work with industry validation requirements and author and execute validation qualification protocols and reports; troubleshoot/problem-solve and risk assessment/mitigation; excellent written and verbal communication skills; able to work independently in a fast-paced environment and manage multiple projects and priorities. Up to 40% remote work allowed.
Full time. $130,106.00 - $152,200 .00 per year. Competitive compensation and benefits.
Qualified applicants can apply at Takeda careers page at: Please reference job #R0115448 . 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.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Lexington, MA
U.S. Base Salary Range:
Kristin Test
$0.00 - $0.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained , certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based e mployee s may be eligible for s hort - t erm and/ or l ong- t erm incentive s . U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
Lexington, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
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