Global Power User Kneat - Validation

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You will have knowledge and leadership in validation and supports business with in-depth knowledge of the Kneat system as a global power user. You will report to the Commissioning, Qualification and Validation Lead. You will guide daily operational maintenance and continuous improvement (user interface, system, technical requirements, system performance and regulatory requirements), reviews and supports the confirmation of major SDLC work, this includes participating in user acceptance testing and the approval of final releases for minor changes.

You will work in cooperation with the manufacturing teams, Engineering, manufacturing science, Regulatory, QC, and Quality Operations on a daily basis and ensures our requirements are met. Checks adherence to global framework (folder structures, templates, naming convention). Support the site power users and manages the CoP of the Kneat system. Participate in escalation and resolution.

You will maintain the framework of business SOPs (end-user, power user SOP as applicable), provides trainings and DEMOs

• Translate industry standards (GMPs, FDA Guidelines), procedures, and regulatory requirements such as (21 CFR Parts 210, 211, 600, ISO 14644, EC-Annex1) into Kneat requirements.

• Lead and work with team members (Engineering, Manufacturing, Regulatory Affairs, Quality Operations, Quality Validation, Supply Chain, and other technical disciplines) representing the validation elements, as applicable

• Review change control requests with potential impact to validated state of validation elements, as applicable.

• Provide training, mentoring and leadership to less experienced staff.

• Monitor and support validation efficiency program on global level

• Guide peers in Validation and Engineering Departments to use sound, statistically and risk based Quality Engineering approaches in project, test plans and in analyses of test results.

• Will identify opportunities for optimization processes within the Kneat tool

• Identify gaps related to validation requirements and adherence to global Validation framework. Drive and close compliance and business gaps as they are identified.

• Participate in assessments. Support process with closure of observations/audit items.

• Present a course of action to management and project team using both written and verbal communication tools.

• Help with regulatory agency inspections, including working with inspectors and corporate/division/internal auditors. Present validation strategy and protocols of Kneat in regulatory inspections.

• Manage other validation personnel, contractors and outside vendors

• Participate in the drafting and implementation of Global procedures including programs for harmonization and streamlining efforts.

• Typically requires BA or BS degree preferably in the engineering or science field. 5+ years of validation experience for non-manager-role

• Experience in manufacturing processes and control systems, cleaning processes, process equipment, facilities and GMP important support systems.

• Experience working with the FDA and other regulatory agencies.

• 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

At Takeda, our patients rely on us to provide 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.

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and excellent 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 provide Better Health and a Brighter Future to people around the world.

This posting excludes Colorado applicants.

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.