Process Validation Engineer (f/m/d)
Singen (Hohentwiel), Baden-WürttembergVaccines prevent 2 to 3 million deaths each year and have transformed global public health. For the past 70 years, Takeda has supplied vaccines to protect the health of people in Japan. Today, Takeda's global vaccine business is applying innovation to tackle some of the world's most challenging infectious diseases, such as dengue, COVID-19, Zika and norovirus. Takeda’s team brings an outstanding track record and a wealth of knowledge in vaccine development, manufacturing and global access to advance a pipeline of vaccines to address some of the world's most pressing public health needs.
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Job Description
Are you looking for a patient-oriented, innovation-driven company that inspires you and promotes your career? Then take your future in your hands and become part of Takeda as a
Process Validation Engineer (f/m/d)
The individual will be expected to provide process validation support for Takeda vaccines manufacturing operations located in Singen and CMOs. The process validation activities related to the Singen & CMO manufacturing site include, but are not limited to, the following areas.
How you will contribute:
Validation subject matter expert to conceive, design and direct the execution of validation/technical shared services projects in support of VBU
Authoring process validation documentation for Lifecycle Process Validation
Oversight and approval of process validation activities, as well as perform data analysis and compilation of data and results into summary and final reports
Align manufacturing processes with executed validation
Participate in regulatory inspections and author, review filing, submission documents
Identify opportunities for continuous improvements, participate in the deployment of best practices, represent process validation at Singen &CMO Work System meetings and support and maintain the process validation communications board and community of practice
Establish, support and direct collaborative projects with other VBU functions for example CMC, External Manufacturing, PO, Quality and External Partners CMOs to generate and execute process and product technology transfers and the associated qualification and validation activities
In this position you will report to the Senior Manager, Vaccines MS&T Validation.
What you bring to Takeda:
You have completed studies in the natural sciences field
Several years of experience in lifecycle process validation in manufacturing operations onsite and with CMOs for commercial and clinical manufacturing
Extended knowledge in Process Performance Qualification, Continued Process Verification, and risk management
Practical experience in vaccine production
Expertise in NPI, process and technology transfer
Excellent English and very good German language skills
What we offer you:
Attractive and competitive salary according to collective bargaining agreement
Open-minded and modern working environment
Hybrid working model
30 vacation days
Company pension plan
Further education and training
Commuting allowance
Attractive Relocation Package including brokerage fees
Subsidized canteen
Subsidized sports programs
Disability insurance
Supplementary nursing care insurance
Long-term account with various possible uses
Employee discounts
Employee Stock Purchase Plan
Group accident insurance
Employee Referral Program
Deferred compensation as desired
Future amount
Global Wellbeing Program
Interactive online courses for employees' children
Employee Recognition Program
About Us:
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines.
In Singen, around 1,200 employees specialize in the production of liquid, semi-solid and freeze-dried medicines. Singen is the only production site in the global Takeda network for the manufacture of our new dengue fever vaccine. Takeda Singen is a regionally significant employer and has been awarded the independent Top Employer certificate several years in a row. The site is characterized by its high level of diversity (e.g., more than 55 nationalities and over 40% of leaders are women), its long company history and its excellent development opportunities. The town of Singen (Hohentwiel) is located on the beautiful Lake Constance in Baden-Württemberg with a view of the Alps and close proximity to France, Liechtenstein, Austria, and Switzerland.
How we will support you:
Takeda is proud of its commitment to create a diverse workforce and to provide equal employment opportunities to all employees and applicants for employment without regard to ethnicity, color, 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. If you are living with disabilities, chronic illness, or neurodiversity, please feel free to let us know so that we can provide you with appropriate support during the application process.
Locations
Singen, GermanyWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeSuccess profile
What makes a successful team member within Vaccines at Takeda?
- Integrity
- Fairness
- Inventive
- Perseverance
- Honesty
- Collaborative
Our leadership
Vaccines represent a new dimension of global impact — successful leadership at Takeda can be encompassed in these four pillars:
Demonstrating strategic enterprise thinking, finding innovative ways to serve patients and build trust, reputation and business
Creating the environment that inspires and enables people to move the organization forward
Focusing on the few priorities and delivers superior results
Elevating the capabilities of the organization for now and the future
Working at Takeda
-
Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team. -
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission. -
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients. -
Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024. -
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family. -
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Patient
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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