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
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
Job description:
About the role :
Takeda's Neuchatel Manufacturing Sciences team is looking for a highly motivated Materials & Process Engineer for a period of 12 months (project).
The role is expected to have a solid understanding of raw material qualification and biopharma DSP validation including related GMP requirements.
Your mission
As Process Validation Specialist you will report directly to the Manufacturing Sciences Manager and be responsible for validating alternatives to mitigate current suppliers stockout. (Covid)
How you will contribute :
Essential Duties & Responsibilities
- Collaborate cross functionally to define minimum requirements for implementation of alternative suppliers of raw materials based on category of material.
- Develop a proposal for alternative suppliers where applicable and gain endorsement through steering committee
- Serve as the communication pathway between CMC teams and Local sites to project governance for reporting project progress, risks, and issues
- Elaborate validation strategy and write validation plan according to Takeda standards procedures.
- Write, review and approve Validation documents (validation protocols/reports, SOPs, RIAS, MVP...etc.) according to Takeda and Regulatory standards
- Participate in validation activities from planning, execution to validation reports
- Coordinate and follow-up validation protocols execution, ensuring that all validation activities and documents are completed and documented in a timely manner.
- Provide Validation support related to strategy definition, problems solving, root cause analysis, CAPAs investigation and implementation steps
- Support writing of regulatory submissions and subsequent responses to questions.
- Participate in internal or external audits, as required. Follow-up on audit observations topics and ensure closure on time
Required profile:
What you bring to Takeda :
Required Skills
- Engineering or university degree (minimum MSc)
- Minimum 2-5 years of experience in process validation for biopharmaceutical manufacturing
- Expertise in single use systems, elemental impurities analysis, extractable and leachables assessments, dual sourcing of raw materials
- Knowledge of proteins and chromatography/ UF (Ultrafiltration) process
- Good knowledge of current Good Manufacturing Practices (cGMP) and quality requirements
- Strong verbal and written communication with ability to effectively communicate at multiple levels in the organization
- Strong organizational and follow-up skills, as well as attention to detail.
- French and English level B1 or higher are a must
What we offer:
What Takeda can offer you:
- Attractive salaries
- Full accident cover
- Participation in health insurance premiums
- Advantageous retirement plans
- Subsidized meal
- Financial participation in the sports practices of its employees
- Transportation: support in local public transport, free parking, carpooling program
- Takeda Neuchâtel offers to its employees an attractive framework and working conditions. The well-being, safety, development and career development of its employees are at the heart of our vision and of our Human Resources, Health, Environment and Safety policies.
- Takeda Neuchâtel is an employer committed to its employees and future generations.
More 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.Empowering our people to shine: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 religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status or any other characteristic protected by law.