Validation Engineer II

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Job Description

Job Title : Validation Engineer II

Location : Lexington, MA

About the role :

As an Validation Engineer II, you will support the ongoing validation activities on the site. You will lead the task of taking the validation strategy outlined in validation project plans or change assessments and develop protocols, using appropriate test scripts. You will accomplish the protocol by demonstrating clear planning, scheduling and coordination with multiple departments. Additionally, upon the completion of the protocol, You will analyze the results, produce any discrepancy reports and complete the final summary report for the protocol. Validation Engineer II is also identified as partners in multiple programs, who aid the senior & principal validation engineers in maintaining the program. You will report to Validation Maintenance Manager.

How you will contribute :

• Perform the following tasks for all validation disciplines of the site, such as Facilities, Utilities and Equipment, Cleaning (CIP / COP), Sterilization (Autoclaves & SIPs), Computer System Validation (PCS / PAS, BMS, CMS, DeltaV, OSI Pi, Statistica, Simca & other Takeda Automation systems), Analytical Instrument Qualification, Chambers, Warehouses & Shipping, Validation Maintenance etc.
• Plan & Coordinate validation activities (including qualification & requalification activities).
• Collaborate with cross-functional team members, such as Engineering, Manufacturing, Quality Assurance, Quality Control, Facilities and other technical disciplines, as applicable, to assemble the validation execution support team.
• Develop, execute and close Qualification & Validation documents, including validation protocols, summary reports, discrepancy reports, periodic reviews, change control tasks etc.
• Analyze results and data generated through protocol execution, summarize results to confirm if protocol acceptance criteria are met, perform trend analyses where applicable, using statistical tools, and ensuring adherence domestic and international GMP regulations, industry standards (GMPs, FDA Guidelines), procedures, and regulatory requirements such as (21 CFR Parts 210, 211, 600, ISO 14644, EC-Annex1). Follow Takeda’s data integrity principles & best practices.
• Lead or participate in investigations related to their protocols and validation scope. Provide accurate information as needed by the investigator to complete the evaluation of cause and corrective actions. Collaborate to conduct risk & impact assessments.
• Use validation test equipment, such as, Ellabsloggers to support validation activities.
• Participate in internal and external audits. Support process with closure of observations / audit items.
• Participate in the site validation group programs to support validation program improvements and collaborate as needed with other validation team members to identify gaps and implement changes.
• Perform reviews / approvals of routine VM or other standard protocols and final reports for other Department members.
• Become a Qualified Trainer for disciplines within the Validation department (Ex : Datalogging Equipment, CIP, SIP, etc.)
• Perform other tasks as directed by the manager.
• Can work with site and global SMEs from External Partners, Engineering, Manufacturing, Quality, Regulatory and EHS to design, execute and deliver to department goals and project goals.
• Participate and work with cross-functional project team members (Engineering, Manufacturing,Quality Control, Quality Operations, Quality Validation, and other technical disciplines) representing the Validation departments strategy and program requirements.
• External contacts include consultants supporting validation and automation activities and members of service organizations such as Ellab.

What you bring to Takeda :

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 :

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

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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 - MA - Lexington - BIO OPS

U.S. Base Salary Range :

67,900.00 - 106,700.00

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 - MA - Lexington - BIO OPS

Worker Type Employee

Worker Sub-Type Regular

Time Type Full time

Job Exempt