Senior Quality Validation Engineer

Job Details
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Job Description
About the role:
The Senior Quality Validation Engineer is in the Validation Quality organization at the Takeda Round Lake aseptic pharmaceutical manufacturing facility. You will work as part of teams providing quality oversight and approval of change control and validation deliverables to ensure that products and processes meet with appropriate regulatory agency validation requirements, internal company standards and current industry practices. This employee will typically focus on disciplines related to equipment, cleaning, process, control system and computer system validations. You will report to the Quality Validation Manager.
How you will contribute:

• Quality Systems/Document Control: Owns Standard Operating Procedures and other Quality System Documentation relevant to their area of expertise. Approve Standard Operating Procedures and other Quality System Documentation relevant to all areas of the plant.
• Training: Develops and delivers training materials relevant to area of expertise. Approve training materials relevant to all areas of the plant.
• Validation Quality: Participates as a team member in the execution and documentation of Validation Master Plans, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Computer System Validation, and Validation Maintenance packages following existing procedures. Review deliverables for compliance to existing requirements. Approve validation documentation (e.g., protocols, CWRs, or risk assessments) that establishes novel requirements or assesses risk.
• Risk Management: Leads teams in the execution of risk management activities.
• Deviations and CAPA: Owns investigations and CAPAs relevant to responsibilities/expertise. Approve investigations and CAPAs relevant to all areas of the plant.
• Change Control: Approves change controls for compliance to existing requirements.
• Quality Leadership: Leads Quality project teams and present to Plant management project plans, progress, and risks. Represent us in areas of expertise to governmental Regulatory bodies.
• Complete assigned training.
• Identifies, escalates, and/or resolves potential compliance and/or safety issues.

What you bring to Takeda:

• Bachelor's degree in science, engineering or other related technical field.
• 4+ years of related experience.
• Proficiency in writing and approving change control and risk assessments processes.
• Experience applying cGMPs. Knowledge of validation principles across multiple disciplines including equipment, facilities, computerized systems and laboratory equipment.
• Stakeholder management skills to manage all partners that support the site.
• Excellent influencing/collaboration skills and teamwork mindset.
• Experience presenting to inspection auditors.
• Knowledge of descriptive statistics. Working knowledge of inferential statistics and related techniques (e.g., sample size determination, comparison analysis, ANOVA, DoE).

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. You may:

• You must not be allergic to Cephalosporin drugs.
• 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.
• Will need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
• May work in a cold, hot or wet environment.
• May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Will work nights, weekends, and holidays to support manufacturing when needed.

More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to 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.
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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 - IL - Round Lake Innovation Park
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 - IL - Round Lake Innovation ParkUSA - IL - Round Lake - Drug Delivery
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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