Engineering Services Lead

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Job Description

About the role:

The Engineering Services Lead is responsible for ensuring that equipment and systems are fully qualified and meet design requirements throughout the asset lifecycle. This role involves overseeing the design and development test plans, validating functional requirements, and benchmarking system performance. By leading teams and projects, this role contributes to Takeda's mission of delivering high-quality products.

How you will contribute:

• Empower, develop, and support staff members to ensure validation requirements are applied as “fit for purpose” for the manufacture of drug substance while meeting Regulatory, Quality, Capacity and EHS requirements.
• Responsible for oversight of the validation maintenance and project activities at the MBO site that includes qualification of equipment, critical systems/utilities, computerized systems, facilities, cleaning and sterilization process qualifications. 
• Provides leadership to validation disciplines during the development of the project requirements, scope, design (concept, basic, and detail), timeline, and budget#
• The incumbent is responsible to improve existing validation processes to ensure compliance while also driving efficiencies.  Provide leadership to all validation related investigations
• Develop and implement strategies to drive efficiencies in cost and time within the validation maintenance and project activities.

Skills and qualifications:

• Engineering degree or equivalent required with a specialization in Chemical, Biochemical, Mechanical or Industrial engineering preferred
• Minimum of 5 years of people leadership experience preferred.
• Demonstrates strong leadership skills, capable of guiding teams to achieve operational success and project goals
• Fully independent in systems engineering tasks, capable of handling highly complex situations and advising others on integration and lifecycle management
• Proven engineering experience in a GMP environment and prior experience interacting with the FDA and other regulatory agencies preferred 
• Thorough knowledge of Validation process in Pharmaceutical Manufacturing and experience in manufacturing processes, control systems, cleaning processes, process equipment, facilities, temperature-controlled units and critical support systems preferred.
• Strong interpersonal skills and communication abilities. Able to manage up and across the organization
• Sound business acumen and ability to align engineering services with business needs and within financial constraints.

As a leader of a functional area or organization, you will set objectives, delegate tasks, and ensure operational success, with reviews by senior management. You will also help shape company policies, tackle complex problems, and meet budgets and schedules. Your responsibilities include managing projects, influencing organizational goals, maintaining frequent communication with peers and customers, and leading teams and projects, serving as a best practice/quality resource.

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:

$154,400.00 - $242,550.00

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.