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Job Description

Title: Principal Engineer

Location: Social Circle, GA

About the Role:

As a Principal Engineer, you will provide process support to the Manufacturing Process by investigating and troubleshooting technical issues within the Social Circle purification manufacturing departments. You will assist your quality and manufacturing partners in maintaining process compliance, aiding in the implementation of yield and process improvements, and supporting process validation activities. As part of the Manufacturing Sciences team, you will report to the Associate Director – Manufacturing Science Fractionation.

How will you contribute:

• Act as protein purification (plasma protein experience preferred) expert to provide technical support for complex manufacturing scale investigations and manufacturing process improvement projects. Devise new approaches to complex problems through adaptations and modifications of standard technical principles. Incorporate new methods and technologies for improving existing or new products/processes.

• Act as subject matter expert with technical and practical knowledge of  protein purification techniques and protein separation techniques (filtration, centrifugation, and/or chromatography).

• Evaluate and prepare complex product impact assessments for process exceptions.

• Support commercial manufacturing operations to meet fulfillment targets (lot release timing). Complete CAPA tasks to ensure on time release of lots; product impact assessments, corrective and preventive actions and root cause investigations as needed.

• Act independently with minimal supervision to initiate and/or conduct studies and improvement projects for product quality, process robustness, product yield and cycle time based on recent technical knowledge.

• May provide training and supervision to junior members within the discipline. Routinely provide advice and assistance to team members regarding unique problems.

• In addition to having an in-depth knowledge and understanding of GxP and related regulations and guidance, is able to provide expert insights into such regulations so as to facilitate efficient product registration and/or is an active participant in the generation, review, adoption and interpretation of such regulations.

• Adhere to quality system, understand and apply applicable corporate, divisional and departmental procedures. Knowledge of related regulations and guidance (e.g., USP, ICH, and regional compendia) to facilitate compliance.

• Present information to internal and external auditors.

• Work with manufacturing and global subject matter experts to identify process improvement opportunities

• Work with appropriate teams to execute improvement projects, including validation support and submission writing

• May work on small scale experiments

• Work with Manufacturing to help promote key metrics such as yields and capacity.

• Author and execute process validation protocols and final reports (e.g. process performance qualification, mixing study, hold study, lifecycle study, etc.). Coordinates and supports training and execution of validation activities. Evaluate results relative to protocol requirements, definitions and/or study goals.  Provide analytical interpretation of result from studies to stakeholders.

• Promote the use of DMAIC tools in problem solving and projects.

• Analyze scientific and statistical data to draw appropriate conclusions.

• Utilize robust statistical analysis to draw appropriate conclusions from the data

What you bring to Takeda:

• Requires a bachelors' degree in preferably in science, engineering, or related scientific field with 15+ years of related experience.

• Advanced degree preferred. (MS, PhD)

• Knowledge of FDA-regulated manufacturing environments.

• Practical and theoretical knowledge of the purification of plasma proteins and biochemistry.

• Ability to solve routine and complex technical problems without assistance.

• Ability to discuss normally encountered technical and project management issues, both verbally and in written form.

• Must have excellent organizational, verbal and written communication skills. Able to efficiently communicate with cross-functional teams and management.

• Has the ability to prioritize multiple tasks and work on multiple projects simultaneously.

• Knowledge of GMPs, FDA guidelines and process validation.

• Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience.

• Ability to manage multiple cross-functional teams simultaneously.

• Must embrace working in a fast-paced, team-oriented, cross-functional environment.

• Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint). Experience with Minitab or other statistical software preferred.

• Strong interpersonal, verbal, and written communication skills. Strong presentation skills.

• Ability to participate in lead teams and work as a collaborative team member.

• Self-driven individual that requires minimal supervision.

• Experience with DOE (Design of Experiments), six sigma, and lean manufacturing a plus.

Other Job Requirements:

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:

U.S. Base Salary Range:

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.

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