Validation Engineer II

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Job Description

Job Title: Validation Engineer II -AIQ

Location: Lexington, MA

About the Role:

As a Validation Engineer II, you will be a member of the Quality Control Organization at the MA Biologics Operations Site and supports QC laboratory operations. You will focus on the execution of analytical instrument lifecycle activities for Quality Control analytical equipment including authoring and execution of analytical instrument lifecycle documents to ensure Quality Control analytical instruments meet applicable regulatory requirements for operation and use. This is a hybrid position located in Lexington, MA. You will report to Associate Director of QC Operations Support.

How you will contribute:

• You will work with stakeholders to understand end user requirements and implement approved solutions.
• You will stay informed about technology trends in the market and evaluate for potential value to the company
• You will execute and deliver tasks that are part of the Quality and Lab of the Future roadmap and existing QC portfolio.
• You will work with project teams (Lab Systems, QC, and QA) during project kick-off and planning to ensure appropriate tasks are accounted for as defined in local and global SOPs
• You will create and update formal and informal department work instructions, tools, and job aids
• Identify areas of improvement and propose solutions to senior staff.
• You will execute qualification of new and upgraded systems with oversight from senior staff.
• 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,
• You will partner with Quality Lab Systems personnel during qualification efforts to ensure optimum operational performance of delivered solutions
• You will provide support during FDA/Regulatory Authority Inspections and Readiness.
• Participate in other QC activities as assigned on various initiatives and/or quality events.
• Determine qualification and testing approach in accordance with Takeda policies and procedures.
• Collaborate with cross-functional team members and subject matter experts to meet project objectives.
• Escalate roadblocks, project delays, and quality issues to project managers and senior staff for resolution.
• Advise internal QC system and process owners on adherence to Takeda policies and requirements. Consult and coordinate with internal application administrators or system owners to complete analytical instrument lifecycle deliverables. Coordinate with external vendors during setup, installation, maintenance, and troubleshooting of laboratory analytical instruments.
• Advise project managers on execution of analytical instrument lifecycle activities.

What you bring to Takeda:

• Minimum BS or BA. Engineering or Science; advanced degree would be ideal; and other job-related experience.
• 3+ 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.
• Good communication and interpersonal skills. Able to clearly and concisely communicate with colleagues and stakeholders.
• Basic investigation techniques to determine true root cause and resolve protocol discrepancies.
• Familiarity with following tools and processes like TrackWise – CAPA, Deviation, Change Control, Veeva – Document Workflows, MS Office
• 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. N
• 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.
• Must be able to lift, push, pull and carry up to 30 lbs.
• In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.

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:

$70,000.00 - $110,000.00

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

YesIt 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.