Validation Engineer II

Company: Takeda Pharmaceutical
Location: Pepperell
Posted on: May 13, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionValidation Engineer IILexington, MAAbout the role:Join Takeda as a Validation Engineer II where you will write, implement, analyze results and summarize process validation activities in the areas of tech transfer, change management, and continuous lifecycle management . You will also develop and assess the following Quality System elements for process Validation including CAPAs and deviations. As part of the Validation Engineering team, you will report to Validation Manager and work with members of the Quality Assurance, Manufacturing, and Engineering organizations to develop process validation studies and projects to enhance the manufacturing processes to compliantly achieve organizational goals. Other departments you will work with include: Process Development, Manufacturing Sciences and Technology, Regulatory Affairs, Quality Control and Facilities. .How you will contribute:

• You will provide technical input to validation activities
• You will Represent process validation during tech transfer activities.
• You will Represent process validation during site GMP activities and participate on cross-functional teams
• You will Support process validation Quality Systems
• You will Identify opportunities for personal and professional development, continuous improvements, help deploy best practices, represent process validation at Lexington Site Work System meetings and support/maintain the process validation communications board.
• You will Participate in regulatory agency inspections for Process ValidationMinimum Requirements/Qualifications:
  • Bachelor's in Chemical/Biochemical/Bioprocess Engineering, Chemistry, Biochemistry, or related field with 5 or more years relevant experience. Master's in related field with 2 or more years relevant experience. PhD. In related field with minimum of 0 years relevant experience.
  • Experience authoring and completing validation studies. Understanding of cGMP requirements for validation documentation. Demonstrate ability to collaborate with multiple functions to implement validation activities and incorporate validation results into routine operational practices
  • Experience authoring & building process validation studies for commercial GMP manufacturing processes including process qualification (PPQ), chromatography resin / membrane lifetime and mixing uniformity studies
  • Experience with troubleshooting / problem-solving and risk assessment / mitigation
  • Working knowledge of the science and technology for the major unit operations associated with manufacturing operationsWhat 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
    • Flexible Work Paths
    • Tuition reimbursementMore about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will 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.In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.#GMSGQ#LI-MA1EEO StatementTakeda 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.LocationsUSA - MA - Lexington - BIO OPSWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Nashua , Validation Engineer II, Engineering , Pepperell, New Hampshire