Senior Validation Engineer

Job Details
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Job Description
About the role:
As Senior Validation Engineer, you will support the operations through the initial qualification to validation maintenance of equipment, systems, facilities, and utilities. Responsible and accountable for performing activities such as Cycle Development (CD), Design Qualification, Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV), and Validation Maintenance. Focused on right first-time execution and continuous improvement. You will report to Head of Engineering Services.
This is an on-site position, and you will be required to work all five days from the office.
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 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 interdepartmental and cross-functional partnerships.
• Maintain a state of inspection readiness and act as SME in Health Authority inspections.
• Approval of commissioning documents, including but not limited to commissioning protocols and reports.
• Evaluate and leverage testing to qualification activities.
• Generate, execute, and manage the detailed project plans and timelines for the execution of CD/DQ/IQ/OQ/PQ/CV/Validation Maintenance, change management activities and their associated documentation.
• Support departmental and capital project validation activities.
• Provide key performance indicators data in a predetermined frequency.
• Owner of change control task of validation activities.
• Execute validation activities aimed at improving Right First-Time.
• Present and provide rationale for the 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, 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. Maintain expertise as necessary to stay abreast of technical and industry advancements.
• Support EHS programs and own CAPA records as needed.
• Accountable for behaviors as described in Takeda Standards, policies, and procedures.

What you bring to Takeda:

• BS engineering with 8+ years' experience in validation.
• Experience with systems like LIMS, MES, ERP, SCADA, or DCS (e.g., Delta V) for computer systems validation engineers.
• Advanced knowledge of equipment, systems, facilities, and utilities in a regulated environment is required. Advanced knowledge of commissioning and qualification of equipment, systems, computerized systems, facility, and utilities is required.
• Familiarity with software development lifecycle (SDLC) and validation tools.
• Knowledge of GAMP 5, FDA 21 CFR Part 11, and other regulatory frameworks.
• A strong technical and/or engineering knowledge, as well as strong ability to work collaboratively with interfaces to Process Engineering, Quality, Project Managers, Facilities, Automation, and other groups.
• Technical expertise to define validation approaches and execution of 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 associated regulations, guidelines, and best practices.
• Proficient in Microsoft Word and Excel, computer software.

Important Considerations At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to 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.

More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
#GMSGQ #ZR1 #LI-MA1
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:
USA - CA - Thousand Oaks - Rancho Conejo
U.S. Base Salary Range:
$86,500.00 - $135,960.00
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 employees may be eligible for short-term and/or long-termincentives. 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 USA - CA - Thousand Oaks - Rancho Conejo
Worker Type Employee
Worker Sub-Type Regular
Time Type Full time
Job Exempt
Yes
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
Company info
Website Location 650 East Kendall Street
Cambridge
MA
02421
United States
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