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Job Description

Job Title : Senior Validation Engineer -AIQ

Location : Lexington, MA

About the Role:

As a Senior Validation Engineer II, you will be a member of the Quality Control Organization at the MA Biologics Operations Site and supports QC laboratory operations. Your primary responsibilities of this position are focused on the execution of analytical instrument lifecycle activities for Quality Control analytical equipment including authoring, reviewing, approving, and executing analytical instrument lifecycle documents, identify and implement continuous improvement of department procedures and processes, manage qualification and technical projects, and oversee and train junior staff. This is a hybrid position located in Lexington, MA. You will report to Associate Director of QC Operations Support.

How you will contribute:

• Determine qualification and testing approach in accordance with Takeda policies and procedures and provide resolution or alternative options to meet requirements on a project basis.

• Collaborate with subject matter experts to determine optimal project plans and resolution to project obstacles.

• Escalate project delays and quality issues when guidance is not provided or unclear.

• Consult and advise internal QC system and process owners on adherence to Takeda and international regulatory compliance requirements.

• Consult and coordinate with internal application administrators or system owners to ensure all regulatory rules are properly administered, tested, or risk assessed.

• Coordinate with external vendors during setup, installation, maintenance, and troubleshooting of laboratory analytical instruments.

• Advise project managers on execution of analytical instrument lifecycle activities.

• Strategic Partnering: Work with stakeholders to understand end user requirements and provide operational oversight for the implementation of approved solutions.

• Stay informed about technology trends in the market and evaluate for potential value to the company

• Plan and Build: Establish and coordinate initiatives that are part of the Quality and Lab of the Future roadmap and existing QC portfolio. You will participate in Business meetings to understand business requirements. you will work closely with project teams (Lab Systems, Capital, Validation, and QA) during planning and design phases to ensure appropriate solutions and consult during the selection of external service providers. You will provide impact assessments with respect to changes to analytical instruments and also create and update formal and informal department work instructions, tools, and job aids

• Run: Function as a subject matter expert for analytical instrument lifecycle. You will lead and execute qualification of new and upgraded systems. You will create lifecycle documentation including System Classifications, Qualification Plans, User Requirements Specifications (URS), Functional Risk Assessments (FRA), Installation and Operational Qualifications (IOQ), Trace Matrices, and Periodic Review Reports.

• Partner with Quality Lab Systems personnel during qualification efforts to ensure optimum operational performance of delivered solutions

• Provide support during FDA/Regulatory Authority Inspections and Readiness.

• Oversee, review, and approve documents created by junior staff.

What you bring to Takeda:

• Minimum BS or BA. Engineering or Science; advanced degree would be ideal; and other job-related experience.

• 7+ years related experience in biopharmaceutical manufacturing environment validation, operations, engineering, or any combination thereof.

• Experience in Pharmaceuticals or Life Sciences industry would be ideal.

• Experience working in GxP laboratory or with analytical instruments would be ideal.

• Knowledge of computer systems and software validation would be ideal.

• Able to clearly and concisely communicate with colleagues and stakeholders.

• Effectively manage time, meet multiple varying deliverables, and prioritize work in a fast-paced environment.

• Ability to apply basic investigation techniques to determine true root cause and resolve protocol discrepancies.

• Familiarity with following tools and processes TrackWise – CAPA, Deviation, Change Control, Veeva – Document Workflows

• Familiarity with Operational Excellence and/or Continuous Improvement processes

• Conducts work in compliance with cGMPs, safety, and regulatory requirements.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Professional training and development opportunities

• Tuition reimbursement

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.

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 - MA - Lexington - BIO OPS

U.S. Base Salary Range:

$96,600.00 - $151,800.00

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-term incentives. 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 - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.