Senior Validation Engineer I / Cleaning and Sterilization - Takeda

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Job Description

You will support site projects, technical transfers, and ongoing validation maintenance on-site at our Covington Georgia facility. You will report to the Manager of Validation. Responsible for the design, authorship, and execution of commissioning, qualification and validation studies for the any or more of the following major disciplines:

• Facilities, Utilities, and Equipment (FUE) qualification
• Units operations automation qualification with Honeywell, Delta V, and PCL-based systems
• Computerized systems validation
• Cleaning validation
• Sterilization validation
• Materials validation
• Process validation

Provide technical subject matter expert (SME) support to change controls, investigations, deviations, and CAPAs. Individual must work on moderate to complex assignments, where analysis of situations or data requires an in-depth evaluation of different factors or intangible variables.

How you will contribute:

• Independently designs, authors, executes and summarizes commissioning, qualification and validation studies. Partner with SMEs to ensure smooth execution of testing strategies.
• Collaboratively conduct risk and impact assessments.
• Support development of standard operating procedures (SOP) and validation assessments.
• Interface with customers on technical issues, project timelines and validation support.
• Participate on 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 validation studies.
• Participate in audits and regulatory agency inspections as a representative of the Engineering Validation team, as required.
• Support development of best demonstrated validation practices within the validation department, based on current industry practices and guidelines.
• Support operations and communications with Program Managers.
• Exercise judgment within defined policies in selecting methods, techniques, and evaluation criteria for obtaining results. May determine methods and procedures on new assignments.
• Demonstrate continuous improvement concerning increasing job knowledge and proficiency related to validation in the biopharmaceutical industry, and technical understanding capability.
• Lead several small projects with complex features.
• Serve on Tier 1 process teams.

What you bring to Takeda:

• Bachelor's degree in Engineering discipline required. Minimum 7 years validation experience for non-manager role; 5+ years experience for Supervisor.
• 7 years of relevant experience in a GMP regulated environment.
• At least 4 years of commissioning, qualification and validation (CQV).
• Validation and system experience in the following applicable areas: Sterilization and aseptic processing validation.
• Process and utility systems validation, temperature mapping, manufacturing equipment commissioning and qualification.
• Protein purification from mammalian plasma and blood.
• Technical experience of automation platforms, such as DeltaV, Honeywell, Rockwell PLC, Siemens XFP.
• Lead validation projects, coordinate contractors, and improve results.
• Direct experience manufacturing operations and biotechnology processes.
• Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments.
• Must possess basic knowledge of core principles in validation disciplines, and be experienced applying project management methodology.
• Knowledge of basic principles in multiple engineering disciplines.
• Interaction with manufacturing, schedulers, maintenance and quality staff to secure equipment allocation to support execution activities.
• Interaction with project managers for schedule adherence.

Important Considerations:

• May work weekends, evenings, off-hours, extended periods of time.
• Occasionally, may lift up to 50 pounds, and be able to stand.
• Need to gown and operate in an environment requiring gowning.
• Up to 10% travel expected.

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