Lead Manufacturing Investigator

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
About the role:
As the Lead Manufacturing Investigator, you will lead evaluation and close out of deviations within the established timelines. You will evaluate and close out Environmental Monitoring excursions and Metrology Out of Tolerance assessments and conduct investigations of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors to determine product impact, identify root cause, and identify corrective and preventative actions. You will report to the Investigations Manager.
How you will contribute:

• Exercise judgment within defined procedures and practices to determine appropriate action.
• Build productive working relationships throughout the organization.
• Investigate and document findings and impact assessment for deviations mostly minor, some major.
• Provide subject matter expertise on manufacturing process to support deviations owned by other departments.
• Author calibration Out of Tolerance (OOT) and Environmental Monitoring (EM) excursions impact assessments
• Participate in continuous improvement initiatives.
• Demonstrate capability to analyze and resolve process related issues of low to mid- level complexity, create new solutions to issues.
• Participate on cross functional teams with internal/external SMEs.
• Assist functional area leads in driving problems to resolution.
• Be an external spokesperson during Health Agency Inspections on minor matters of investigations.

What you bring to Takeda:

• Bachelor's in Science, Engineering or a related discipline
• 2+ years related experience in the manufacturing and/or development of biologics or pharmaceuticals
• Previous technical writing experience would be ideal
• Proficient with Microsoft Office products including Visio, Project and SharePoint.
• Experience with Trackwise or equivalent system

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 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 a cold and/or wet environment.
• Must be able to work multiple shifts, including weekends.
• May be required to work in a confined area.
• Some Clean Room and cool/hot storage conditions.

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.
This posting excludes Colorado applicants.
#GMSGQ #ZR1 #LI-1
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