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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, Ellabs loggers 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:

• 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. 
• Demonstrate basic experience in validation disciplines (equipment, facilities, critical systems, computer, cleaning, process to also include HVAC and sterilization) and have a working knowledge of chemistry and microbiology would be ideal.
• Experience in manufacturing processes and control systems (e.g. Allen-Bradley PLC, Delta V, BAS, Siemens), cleaning processes, process materials, process equipment, facilities and critical support systems (utilities) would be ideal.
• Apply deep understanding of cGXPs, GAMP5 and 21CFR Part 11 (as applicable), relevant SOP curriculum, routine project procedures, and other training. 
• Experience in Trackwise, Veeva, Kneat, or other common electronic documentation systems would be ideal.
• Support projects that require team participation. 
• Interact with individuals at all levels of organization & departments.
• Flexibility to address and changes in approaches in work environments.
• Demonstrate daily job activities and the Quality Systems and Validation principles in use at Takeda’s MA Bio Ops sites.
• Demonstrate ability to learn Regulations in the following markets: US, EU, ICH and China GMP guidelines/requirements, current trends and expectations of Quality Risk Management.
• Manage priorities in alignment with site drivers. 

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:

• May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
• 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.
• Will work mostly in office environment with requirements to work in manufacturing and support areas. 
• Must be able to work multiple shifts, with occasional work including weekends and extended hours, as required.
• Will work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment. 
• Will work in Cleanrooms, including cold/hot storage conditions. 
• May work in a loud area that requires hearing protection and other protective equipment to be worn. 
• Must have the ability to work in confined spaces (e.g. attic space, engine rooms and tanks). 
• Will work around chemicals, such as alcohol, acids, buffers, and celite, that may require respiratory protection 
• Validation personnel are located in Lexington, MA.  Occasional travel may be required to other Takeda MA Bio Ops facilities.

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.

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