Principal Project Engineer

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Job Description

About the role:

This position reports to the Associate Director, Process Engineering. Responsibilities include support of aseptic filling operations and cross-functional improvement activities interacting with Manufacturing, Quality, Reliability Engineering, and Supply Chain. The incumbent will provide technical expertise in areas such as aseptic filling technologies, process optimization, deviation investigation. The role also requires familiarity with GxP principles relevant to pharmaceutical industry and experience managing change control.

How you will contribute:

• Identify and implement projects to improve quality and/or efficiency of custom commercial filling lines.

• ​Act as technical leader in support of Quality and Manufacturing

• Lead technical aspects of change requests, Non-conformance/CAPA, and operational improvement programs.

• Lead troubleshooting of components and equipment issues to improve process OEE.

• Support Manufacturing and Maintenance with troubleshooting and training

• Lead yield improvement efforts as related to solution loss, overfill, and defects

• Develop and disseminate technical insight and knowledge in fill-finish operations

• Develop expertise in effect of filling/finishing operations on biologics.

• Act as liaison with Regulatory on projects requiring regulatory submissions.

• Support the site during inspections as one of the technical experts.

What you bring to Takeda:

• Bachelor’s degree in Engineering discipline required (preferably Mechanical, Mechatronics, or Chemical)

• 5+ years of related experience

• Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.

• Must have demonstrated ability to provide technical leadership and insight with measurable impact on manufacturing process performance.

• Must have demonstrated ability to lead projects, coordinate contractors, and direct the activities of technicians.

• Must have the ability to organize and present technical and project management overviews.

• Must have good verbal/written communication skills, including creation and presentation of project proposals to senior management.

• Must have experience with Biotechnology / pharmaceutical manufacturing operations such as aseptic filling, packaging, and their support systems such as CIP, SIP, plant and clean utilities.

• Must have advanced technical aptitude to troubleshoot, identify and propose solution for the system downtime root case.

• Must have ability to author user and technical specification, electrical schematics, mechanical drawings, technical protocols and reports.

• Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint) MS Project, Auto-Cad and Solid Works.

• Must be detail focused and willing to take ownership of outcomes

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:

• May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.

• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

• Work in a cold, wet environment.

• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

• Must be able to work non-traditional work hours, including weekends and holidays, as needed.

• In general, the position requires a combination of sedentary work and walking around observing conditions of the facility.

• Must be able to carry up to 25lbs, lift up to 25lbs, push/pull up to 25lbs (with assistance of material handling equipment)

• During observations and inspections: Must be able to stand and/or walk for an extended period of time over an 8-12 hour shift between rooms and across the site.

• Indoor working conditions

• General office environment with air conditioning and heating

• Will work around moving equipment and machinery during observations

• During observations and inspections: May be required to work in confined spaces/areas.

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.

#GMSGQ #ZR1

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 - IL - Round Lake - Drug Delivery

U.S. Base Salary Range:

$96,600.00 - $151,800.00

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.

LocationsUSA - IL - Round Lake - Drug Delivery

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time

Job Exempt

Yes