BioSpace
Senior Validation Engineer
Company:
Takeda
Location:
USA – CA – Thousand Oaks – Rancho Conejo
Job Type:
Full time, Employee, Regular
Salary Range:
$86,500 – $135,960
Job Description As a Senior Validation Engineer, you will support the operations through the initial qualification to validation maintenance of equipment, systems, facilities, and utilities. You will be responsible for performing activities such as Cycle Development, Design Qualification, Commissioning and Qualification, Performance Qualification, Cleaning Validation, and Validation Maintenance. The focus is on right first‑time execution and continuous improvement. You will report to the Head of Engineering Services and will work on site five days a week.
Responsibilities
Be a Validation Engineering representative and technical subject‑matter expert (SME) on cross‑functional and multi‑site teams related to equipment, systems, utilities, facilities, and computerized systems as applicable to its assigned role.
Create validation documentation including SOPs, risk assessments, traceability matrices, and validation master plans.
Develop validation protocols (IQ/OQ/PQ) for computer systems as applicable to its assigned role.
Apply advanced theory, technical principles, and expert judgment to address a broad range of problems.
Troubleshoot and direct the resolution of Validation issues by fostering effective inter‑departmental and cross‑functional partnerships.
Maintain a state of inspection readiness and act as SME in Health Authority inspections.
Approve commissioning documents, including but not limited to commissioning protocols and reports.
Evaluate and leverage testing for qualification activities.
Generate, execute, and manage detailed project plans and timelines for the execution of CD/DQ/IQ/OQ/PQ/CV/Validation Maintenance, change‑management activities, and associated documentation.
Support departmental and capital project validation activities.
Provide key performance indicator data on a predetermined frequency.
Own change‑control tasks of validation activities.
Execute validation activities aimed at improving Right First‑Time.
Present and provide rationale for completed work during periodic audits and Health Authority inspections.
Coordinate and perform tactical activities, including sample collection, coordination with cross‑functional support teams, data and result retrieval, and documentation completion as required by protocols.
Coordinate and perform equipment and system re‑qualification according to procedures and predetermined timelines.
Foster an environment that encourages continuous learning and maintain expertise to stay abreast of technical and industry advancements.
Support EHS programs and own CAPA records as needed.
Be accountable for behaviors as described in Takeda standards, policies, and procedures.
Qualifications
BS engineering with 8+ years of experience in validation.
Experience with systems such as LIMS, MES, ERP, SCADA, or DCS (e.g., Delta V) for computer‑systems validation.
Advanced knowledge of equipment, systems, facilities, and utilities in a regulated environment, including commissioning and qualification of equipment, systems, computerized systems, facilities, and utilities.
Familiarity with software development lifecycle (SDLC) and validation tools.
Knowledge of GAMP 5, FDA 21 CFR Part 11, and other regulatory frameworks.
Strong technical and engineering knowledge and ability to collaborate with Process Engineering, Quality, Project Management, Facilities, Automation, and other groups.
Technical expertise to define validation approaches and execute system validation activities in accordance with cGMP and applicable regulations and industry guidance.
Advanced understanding of data and statistical analysis of validation test results.
Basic understanding of data and statistical analysis of validation test results.
Knowledge of cGMPs or equivalent regulations, validation‑associated regulations, guidelines, and best practices.
Proficient in Microsoft Word, Excel, and computer software.
Key Environmental Considerations
Work in a controlled environment requiring special gowning and protective clothing for head, face, hands, feet, and body; may include hearing protection for loud areas.
Remove all make‑up, jewelry, contact lenses, nail polish, and/or artificial fingernails while in the manufacturing environment.
Work in a cold, wet environment.
Work multiple shifts, including weekends, or be asked to work supplemental hours as necessary.
Work around chemicals such as alcohol, acids, buffers, and Celite that may require respiratory protection.
The overall physical exertion of this position is light work.
Able to work in controlled or clean‑room environments requiring special gowning.
May be required to work or be assigned to a different shift as needed.
May require availability outside regular business hours.
Pace may be fast and job completion demands may be high.
Compensation and Benefits Base salary ranges from $86,500 to $135,960. In addition, employees may be eligible for short‑term and/or long‑term incentives, medical, dental, vision insurance, a 401(k) plan with company match, short‑term and long‑term disability coverage, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, and well‑being benefits. Paid sick time up to 80 hours per calendar year and paid vacation up to 120 hours for new hires.
EEO Statement Takeda is proud of 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.
Additional Information Job Exempt:
Yes
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Takeda
Location:
USA – CA – Thousand Oaks – Rancho Conejo
Job Type:
Full time, Employee, Regular
Salary Range:
$86,500 – $135,960
Job Description As a Senior Validation Engineer, you will support the operations through the initial qualification to validation maintenance of equipment, systems, facilities, and utilities. You will be responsible for performing activities such as Cycle Development, Design Qualification, Commissioning and Qualification, Performance Qualification, Cleaning Validation, and Validation Maintenance. The focus is on right first‑time execution and continuous improvement. You will report to the Head of Engineering Services and will work on site five days a week.
Responsibilities
Be a Validation Engineering representative and technical subject‑matter expert (SME) on cross‑functional and multi‑site teams related to equipment, systems, utilities, facilities, and computerized systems as applicable to its assigned role.
Create validation documentation including SOPs, risk assessments, traceability matrices, and validation master plans.
Develop validation protocols (IQ/OQ/PQ) for computer systems as applicable to its assigned role.
Apply advanced theory, technical principles, and expert judgment to address a broad range of problems.
Troubleshoot and direct the resolution of Validation issues by fostering effective inter‑departmental and cross‑functional partnerships.
Maintain a state of inspection readiness and act as SME in Health Authority inspections.
Approve commissioning documents, including but not limited to commissioning protocols and reports.
Evaluate and leverage testing for qualification activities.
Generate, execute, and manage detailed project plans and timelines for the execution of CD/DQ/IQ/OQ/PQ/CV/Validation Maintenance, change‑management activities, and associated documentation.
Support departmental and capital project validation activities.
Provide key performance indicator data on a predetermined frequency.
Own change‑control tasks of validation activities.
Execute validation activities aimed at improving Right First‑Time.
Present and provide rationale for completed work during periodic audits and Health Authority inspections.
Coordinate and perform tactical activities, including sample collection, coordination with cross‑functional support teams, data and result retrieval, and documentation completion as required by protocols.
Coordinate and perform equipment and system re‑qualification according to procedures and predetermined timelines.
Foster an environment that encourages continuous learning and maintain expertise to stay abreast of technical and industry advancements.
Support EHS programs and own CAPA records as needed.
Be accountable for behaviors as described in Takeda standards, policies, and procedures.
Qualifications
BS engineering with 8+ years of experience in validation.
Experience with systems such as LIMS, MES, ERP, SCADA, or DCS (e.g., Delta V) for computer‑systems validation.
Advanced knowledge of equipment, systems, facilities, and utilities in a regulated environment, including commissioning and qualification of equipment, systems, computerized systems, facilities, and utilities.
Familiarity with software development lifecycle (SDLC) and validation tools.
Knowledge of GAMP 5, FDA 21 CFR Part 11, and other regulatory frameworks.
Strong technical and engineering knowledge and ability to collaborate with Process Engineering, Quality, Project Management, Facilities, Automation, and other groups.
Technical expertise to define validation approaches and execute system validation activities in accordance with cGMP and applicable regulations and industry guidance.
Advanced understanding of data and statistical analysis of validation test results.
Basic understanding of data and statistical analysis of validation test results.
Knowledge of cGMPs or equivalent regulations, validation‑associated regulations, guidelines, and best practices.
Proficient in Microsoft Word, Excel, and computer software.
Key Environmental Considerations
Work in a controlled environment requiring special gowning and protective clothing for head, face, hands, feet, and body; may include hearing protection for loud areas.
Remove all make‑up, jewelry, contact lenses, nail polish, and/or artificial fingernails while in the manufacturing environment.
Work in a cold, wet environment.
Work multiple shifts, including weekends, or be asked to work supplemental hours as necessary.
Work around chemicals such as alcohol, acids, buffers, and Celite that may require respiratory protection.
The overall physical exertion of this position is light work.
Able to work in controlled or clean‑room environments requiring special gowning.
May be required to work or be assigned to a different shift as needed.
May require availability outside regular business hours.
Pace may be fast and job completion demands may be high.
Compensation and Benefits Base salary ranges from $86,500 to $135,960. In addition, employees may be eligible for short‑term and/or long‑term incentives, medical, dental, vision insurance, a 401(k) plan with company match, short‑term and long‑term disability coverage, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, and well‑being benefits. Paid sick time up to 80 hours per calendar year and paid vacation up to 120 hours for new hires.
EEO Statement Takeda is proud of 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.
Additional Information Job Exempt:
Yes
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