BioSpace
About the role
Senior Validation Engineer at BioSpace. You will support the operations through the initial qualification to validation maintenance of equipment, systems, facilities, and utilities. Responsibilities include Cycle Development (CD), Design Qualification, Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV), and Validation Maintenance. Focus is on right first-time execution and continuous improvement. This is an on-site position and you will be required to work all five days from the office. Head of Engineering Services, reporting line. How You Will Contribute
Be a Validation Engineering representative and technical subject matter expert (SME) on cross-functional and multi-site teams related to equipment, systems, utilities, facility, and computerized systems as applicable to the 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 the 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 interdepartmental and cross-functional partnerships. Maintain a state of inspection readiness and act as SME in Health Authority inspections. Approve commissioning documents, including commissioning protocols and reports. Evaluate and leverage testing to qualification activities. Generate, execute, and manage detailed project plans and timelines for CD/DQ/IQ/OQ/PQ/CV/Validation Maintenance, change management activities, and associated documentation. Support departmental and capital project validation activities. Provide key performance indicators data at a predetermined frequency. Own change control tasks for 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, coordinating with cross-functional support teams, retrieving data and results, and completing documentation as required per 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 on technical and industry advancements. Support EHS programs and own CAPA records as needed. Act in alignment with Takeda Standards, policies, and procedures. What You Bring To Takeda
BS engineering with 8+ years of experience in validation. Experience with systems like 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; knowledge of 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/or engineering knowledge and ability to collaborate with Process Engineering, Quality, Project Managers, Facilities, Automation, and other groups. Technical expertise to define validation approaches and execute system validation activities in accordance with cGMP and applicable regulations, procedures, 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-related regulations, guidelines, and best practices. Proficient in Microsoft Word and Excel and related computer software. Important Considerations
Role involves working in controlled environments with gowning and PPE; may include additional protective equipment in noisy areas. May require removal of makeup and other accessories in manufacturing areas. Potential for cold or wet environments and multiple shifts, including weekends or additional hours as needed. Possible exposure to chemicals requiring respiratory protection. Physical exertion is light; may be required to work in controlled or clean room environments. May be assigned to different shifts or extended hours as needed. More About BioSpace
BioSpace is focused on transforming patient care through innovative science and collaboration. This description preserves the essential company emphasis and the role’s responsibilities and qualifications without extraneous job-board boilerplate. EEO Statement
Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or any other protected characteristic in accordance with applicable laws.
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Senior Validation Engineer at BioSpace. You will support the operations through the initial qualification to validation maintenance of equipment, systems, facilities, and utilities. Responsibilities include Cycle Development (CD), Design Qualification, Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV), and Validation Maintenance. Focus is on right first-time execution and continuous improvement. This is an on-site position and you will be required to work all five days from the office. Head of Engineering Services, reporting line. How You Will Contribute
Be a Validation Engineering representative and technical subject matter expert (SME) on cross-functional and multi-site teams related to equipment, systems, utilities, facility, and computerized systems as applicable to the 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 the 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 interdepartmental and cross-functional partnerships. Maintain a state of inspection readiness and act as SME in Health Authority inspections. Approve commissioning documents, including commissioning protocols and reports. Evaluate and leverage testing to qualification activities. Generate, execute, and manage detailed project plans and timelines for CD/DQ/IQ/OQ/PQ/CV/Validation Maintenance, change management activities, and associated documentation. Support departmental and capital project validation activities. Provide key performance indicators data at a predetermined frequency. Own change control tasks for 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, coordinating with cross-functional support teams, retrieving data and results, and completing documentation as required per 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 on technical and industry advancements. Support EHS programs and own CAPA records as needed. Act in alignment with Takeda Standards, policies, and procedures. What You Bring To Takeda
BS engineering with 8+ years of experience in validation. Experience with systems like 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; knowledge of 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/or engineering knowledge and ability to collaborate with Process Engineering, Quality, Project Managers, Facilities, Automation, and other groups. Technical expertise to define validation approaches and execute system validation activities in accordance with cGMP and applicable regulations, procedures, 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-related regulations, guidelines, and best practices. Proficient in Microsoft Word and Excel and related computer software. Important Considerations
Role involves working in controlled environments with gowning and PPE; may include additional protective equipment in noisy areas. May require removal of makeup and other accessories in manufacturing areas. Potential for cold or wet environments and multiple shifts, including weekends or additional hours as needed. Possible exposure to chemicals requiring respiratory protection. Physical exertion is light; may be required to work in controlled or clean room environments. May be assigned to different shifts or extended hours as needed. More About BioSpace
BioSpace is focused on transforming patient care through innovative science and collaboration. This description preserves the essential company emphasis and the role’s responsibilities and qualifications without extraneous job-board boilerplate. EEO Statement
Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or any other protected characteristic in accordance with applicable laws.
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