Job Description

You will support site projects, technical transfers, and ongoing validation maintenance. 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, and 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 multiple factors or intangible variables.

How you will contribute:

Responsibilities

• Independently designs, authors, executes and summarizes commissioning, qualification and validation studies. Partner with SMEs to ensure efficient 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 teams to determine the 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 product teams.

What you bring to Takeda:

Education and Experience Requirements

• 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.
• Cleaning validation of manufacturing equipment.
• 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 increase results.
• Direct experience manufacturing operations and biotechnology processes.
• Will break down complex problems and tasks into manageable activities.
• 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.

Internal and External Contacts

• Interaction with manufacturing, schedulers, maintenance and quality staff to secure equipment allocation to support execution activities.
• Interaction with project managers for schedule adherence.

Other Job Requirements

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

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs and company match of charitable contributions
• Family Planning Support
• Professional development opportunities
• Tuition reimbursement

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:

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

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best 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.

This posting excludes Colorado applicants.

How to Apply

Job Types: Full-Time. Salaries: 100,000 and above.

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