Senior Engineer - Fractionation - Takeda

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Job Description

About the role:

Join Takeda as a Sr. Engineer where you will provide process support to the Fractionation manufacturing group by solving technical issues within the Social Circle Fractionation manufacturing facility. 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 Fractionation Manufacturing Sciences team, you will report to the Associate Director of Manufacturing Sciences, Fractionation.

How you will contribute:

• Troubleshoot and provide resolution to technical issues to support ramp-up and steady-state operations of pharmaceutical manufacturing facilities.
• Solve routine design and engineering tasks. Select sound techniques and make design recommendations under the direction of manager. Prepare technical reviews and responsible for organizing data and preparing appropriate documentation for assigned projects.
• Evaluate and prepare product impact assessments for process exceptions.
• Provide training and assistance to team members, manufacturing, and quality regarding analytical and process problems.
• Make sound technical recommendations and contribute to technical feasibility analysis regarding projects/matters.
• Independently plan and implement a series of design and technical tasks that may not be well-defined, have multiple variables, and require advanced techniques within negotiated deadlines.
• Design new approaches to complex problems through adaptations and modifications of standard technical principles. Incorporate new methods and technologies for improving all products/processes.
• Evaluate results relative to protocol requirements, definitions and study goals. Provide analytical interpretation of result from studies to partners.
• Use statistical analysis to draw appropriate conclusions from the data.
• Follow 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 auditors.
• Troubleshoot and provide resolution to technical issues to support ramp-up and steady-state operations of pharmaceutical manufacturing facilities.
• Solve technical manufacturing issues, either lead teams or be an important member of the team.
• Work with manufacturing to identify improvement opportunities.
• Work with appropriate teams to implement improvement projects, including validation support and submission writing.
• May work on small scale experiments.
• Work with Manufacturing to help promote important metrics such as yields and capacity.
• Support teams to resolve complex problems.
• Author and implement process validation protocols and final reports (e.g. process performance qualification, mixing study, hold study). Coordinate and support training and execution of validation activities.
• Promote the use of DMAIC tools in projects.
• Analyze scientific, and statistical data to draw appropriate conclusions.
• Practical and theoretical knowledge of the precipitation and purification of plasma proteins and biochemistry.
• Experience with engineering principles in different scientific disciplines.
• Discuss normally encountered technical and project management issues, both verbally and in written form.
• Effectively communicate with teams and management and prioritize tasks and projects simultaneously.
• Must be adept with engineering and project skills.
• Must be experienced using MS Office software (Word, Excel and PowerPoint). Experience with Minitab or other statistical software preferred.
• Participate in lead teams and work as a collaborative team member.
• Individual that requires minimal guidance.
• Experience with DOE (Design of Experiments), six sigma, and lean manufacturing a plus.

What You Bring to Takeda:

• BS engineering and 4+ years related experience.
• Knowledge of FDA-regulated manufacturing environments is desired.

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. You may:

• May work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Will need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• May work in a cold, hot or wet environment.
• May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Work shifts including nights, weekends, and holidays to support project execution on an infrequent basis (< 5%).
• Ability to work in a clean room environment for extended periods of time.
• Wear personal protective equipment (such as hard hats, safety shoes, safety glasses, ear plugs) due to safety requirements in specific areas.
• Ability to travel on an infrequent basis (< 5 %).

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 to 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-Onsite

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 - GA - Social Circle - Hwy 278

U.S. Base Salary Range:

$84,000.00 - $132,000.00

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-termincentives. 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 - GA - Social Circle - Hwy 278

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time