Quality Assurance Engineer
7 days ago
We are seeking a highly skilled Validation Specialist to join our team at Takeda Pharmaceutical Company Ltd. 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 and Execution of Validation Studies: Independently design, author, execute, and summarize commissioning, qualification, and validation studies for various disciplines, including facilities, utilities, and equipment qualification, computerized systems validation, cleaning validation, sterilization validation, and process validation.
- Technical Expertise: Provide technical subject matter expert (SME) support to change controls, investigations, deviations, and CAPAs, and work on moderate to complex assignments that require in-depth evaluation of different factors or intangible variables.
- Collaboration and Communication: Collaborate with SMEs to ensure efficient execution of testing strategies, conduct risk and impact assessments, and support development of standard operating procedures (SOP) and validation assessments.
- Project Management: Lead several small projects with complex features, serve on Tier 1 process teams, and participate in audits and regulatory agency inspections as a representative of the Engineering Validation team.
- Continuous Improvement: Demonstrate continuous improvement for increasing job knowledge and proficiency related to validation in the biopharmaceutical industry, and technical understanding/problem-solving capability.
- Education: Bachelor's degree in Engineering discipline preferred.
- Experience: Minimum 5 years validation experience for this non-manager role, minimum 7 years of relevant experience in a GMP regulated environment, and at least 4 years of commissioning, qualification, and validation (CQV) desired.
- Skills: 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, and experience with automation platforms, such as DeltaV, Honeywell, Rockwell PLC, Siemens XFP.
Takeda 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, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state, and local laws.
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