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Job Description

About the role:

Computerized Systems Validation Engineer I is responsible for supporting the engineering operations within the organization. This role involves applying theoretical knowledge to practical scenarios, ensuring quality, safety, and performance standards are met in production processes. The role supports Takeda's mission by ensuring reliable and efficient engineering operations.

How you will contribute:

• Support site projects, technical transfers, and ongoing validation maintenance. Primarily responsible for the design, authorship, and execution of commissioning, qualification and/or validation studies for any of the following major disciplines:

• Assist in testing equipment

• Ensure standards of quality, cost, safety, reliability, and performance are met in production processes

• Interpret plans, drawings, and specifications

• Apply basic physics principles in routine situations

• Engage in systems engineering with a foundational understanding of system integration

• Perform basic software engineering tasks by following predefined rules

• Facilities, Utilities, and Equipment (FUE) PCS qualification

• Unit operations automation qualification with Honeywell, Delta V, and PLC- based systems

• Computerized systems validation

• Provide technical support to change controls, investigations, deviations, and CAPAs. Individuals must work on simple to moderate assignments, where analysis of situations or data requires an in-depth evaluation of various factors or intangible variables.

• Independently designs, authors, executes and summarizes commissioning, qualification and/or validation studies. Partners with SMEs to ensure smooth and efficient execution of testing strategies.

• Collaboratively participates in risk and impact assessments.

• Supports development and review of standard operating procedures (SOP) and validation assessments.

• Interfaces with customers on technical issues, project timelines and validation support.

• Actively participates in cross functional teams to determine the root cause and corrective actions for problems associated with investigations.

• Calculation and interpretation of data for commissioning, qualification and/or validation studies.

• Participates in audits and regulatory agency inspections as a representative of the Engineering Validation team, as required.

• Supports development of best demonstrated validation practices within the validation department, based on current industry practices and guidelines.

• Provides support for operations and communications with Program Managers.

• Exercise judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. May determine methods and procedures on new assignments.

• Demonstrates continuous improvement with respect to increasing job knowledge and proficiency related to validation in the biopharmaceutical industry, as well as technical understanding/problem solving capability.

• Participates in several small projects with simple to medium complexity features.

• Serves on Tier 1 work stream teams.

What you bring to Takeda:

• Bachelor’s degree in an Engineering discipline, preferred, or related computerized systems fields.

• Relevant experience in a GMP regulated environment is a plus.

• Knowledge of basic principles in various engineering disciplines.

• Minimum experience requirements of recently graduated up to 2 years in CQV and / or CSV desired.

• Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments is a plus.

• Strong organizational skills, excellent writing and communication skills.

• Knowledge with Microsoft office including Word, Excel, and PowerPoint. Microsoft Project and Visio are a plus.

• Knowledge of paperless validation is a plus.

• Validation and/or system experience in the following applicable areas is a plus: Utility systems validation, temperature mapping, manufacturing equipment commissioning and qualification. Protein purification from mammalian plasma and/or blood. Technical understanding and experience of automation platforms, such as DeltaV, Honeywell, Rockwell PLC, Siemens XFP. Direct experience with manufacturing operations and biotechnology processes is strongly 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. In this role, you 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.

• 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.

• May be required to work weekends, evenings, off-hours, extended periods of time.

• Occasionally, it may be required to lift items weighting up to 50 pounds, and be able to walk, stand, reach and stoop.

• Needs to be able to gown and operate in an environment requiring gowning.

• Up to 10% of travel expected.

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  #LI-MA1

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:

$58,400.00 - $91,740.00

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 - GA - Social Circle - Hwy 278

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes