Manufacturing Process Definition & Improvement, Manager

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Job Description
About the role:
As the Manufacturing Process Definition & Improvement, Manager you will be responsible for ensuring the quality of processes and product outputs. This role involves defining activities, processes, and standards to meet quality requirements, auditing and monitoring processes, and reporting on deviations and defects. By optimizing manufacturing processes, this role supports Takeda's mission to deliver high-quality products. You will report into the MES Business Owner.
How you will contribute:

• Define and specify activities, processes, and standards to meet quality requirements
• Audit and monitor processes to ensure compliance with internal and regulatory standards
• Conduct product integrity testing and ensure compliance with quality requirements
• Report on process deviations and defects
• Manage large projects or processes
• Coach, review, and delegate work to lower-level professionals
• Lead small project teams and participate in training junior staff

Minimum Requirements/Qualifications:

• Bachelor's Degree
• Minimum of 5 years overall experience, including at least 3 years' experience working on MES projects in the Life Sciences industry
• Deployment experience with plant floor/Manufacturing Execution Systems (MES) solutions (e.g. Syncade, Rockwell, ProPack Data, Werum PAS-X)
• Knowledgeable in FDA validation requirements preferred, including: User Requirement and Design Specs, Business Process Procedures, Design Reviews, Requirements gathering
• Experience with SDLC (Waterfall/Agile)
• Experience developing user requirements, functional specification documents and test scripts for MES projects
• Demonstrate understanding of Networking & System Security Fundamentals and knowledge of S88, S95, OPC, Data Historian, System Interfaces, Distributed Control Systems, etc.

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 position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
#LI-Hybrid
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:
$111,800.00 - $175,670.00
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.