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Validation Specialist
2 months ago
We are seeking a highly skilled Validation Specialist to join our team at Takeda Pharmaceuticals. As a key member of our Engineering Validation team, you will play a critical role in ensuring the quality and integrity of our products.
Key Responsibilities- Design, author, and execute commissioning, qualification, and validation studies for various disciplines, including facilities, utilities, and equipment, as well as computerized systems and process validation.
- Provide technical subject matter expert (SME) support to change controls, investigations, deviations, and CAPAs, working on moderate to complex assignments that require in-depth evaluation of different factors or intangible variables.
- Collaborate with SMEs to ensure efficient execution of testing strategies and conduct risk and impact assessments.
- Support the development of standard operating procedures (SOPs) and validation assessments, as well as work with customers on technical issues, project timelines, and validation support.
- Participate in audits and regulatory agency inspections as a representative of the Engineering Validation team, as required.
- Support the development of best demonstrated validation practices within the validation department, based on current industry practices and guidelines.
- Bachelor's degree in an Engineering discipline preferred.
- Minimum 5 years of validation experience for this non-manager role.
- Minimum 7 years of relevant experience in a GMP regulated environment.
- At least 4 years of commissioning, qualification, and validation (CQV) desired.
- Knowledge of industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments.
- Proficient with Microsoft Office, including Word, Excel, and PowerPoint. Microsoft Project and Visio a plus.
We are looking for a highly motivated and experienced professional who can bring their expertise and passion for validation to our team. If you are a detail-oriented and organized individual with excellent communication skills, we encourage you to apply.
About TakedaTakeda is a patient-focused company that is transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. We are committed 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 protected by law.
