Analytical Instrument Lifecycle

Job Posting Description

**About the Role**:

- The Takeda site in Orth an der Donau looks back on a history of more than 40 years. We are experts in the development, production and analytical testing of biological, plasma and recombinant products._
- At Takeda’s Orth an der Donau site, we are at the forefront of digital transformation, implementing state-of-the-art automated and connected analytical systems for biopharmaceutical quality control. As part of the Quality Control Team, you will actively contribute to the qualification, implementation, and continuous optimization of digital and automated laboratory processes supporting the release and stability testing of biological, plasma and recombinant products._
- You will collaborate closely with colleagues in Quality Control, Data Science, IT, and Manufacturing at both local and global levels, supporting digital QC and Analytical Instrument Qualification initiatives across several product platforms._

**How you will contribute**:

- Independently manage end-to-end analytical instrument lifecycle processes, including CAPEX requests, execution of assigned work packages, drafting User Requirement Specifications, and participation in instrument qualification, validation maintenance, audit trail review, and decommissioning activities.
- Support the documentation and operational aspects of instrument decommissioning as part of lifecycle management.
- Assist in the execution of lab digitalization projects, including instrument connectivity, automation workflow orchestration, and LIMS support.
- Actively participate in the implementation and continuous improvement of the AGILE Operating System (e.g., LabExcellence, AOS tools) by identifying and realizing optimization opportunities within the own area of responsibility.

**Analytical Instrument Lifecycle Management**:

- Support budget planning and CAPEX requests incl. cross-functional alignment (user, engineering/external parties, DD&T, etc.)
- Prepare User Requirement Specifications (URS)
- Ensure data integrity (ALCOA+) and traceability including 21 CFR Part 11 and GxP considerations
- Perform and document analytical instrument qualification & computerized system validation
- Plan and execute instrument decommissioning
- Support regulatory interactions and audits

**AGILE Operating System (LabExcellence, AOS Tools)**:

- Drive the implementation of LabExcellence tools and Lab of the future initiatives
- Provide support for employees
- Periodic reporting of progress into global functions
- Continuously optimize laboratory processes

**Interfacing Analytical Instruments & LIMS Support**:

- Lead and execute lab instrument interface projects (e.g. bi-directional instrument - LIMS connectivity)
- As appropriate, evaluate, select, and manage vendors/partners for instrumentation integrations
- Set up and test interfaces as well as provide support for validation
- Interface with local & global DD&T

**Data Science**:

- Perform data analyses and create queries/dashboards/control charts, etc. following SDLC standards
- Mentor and upskill scientists and data practitioners
- Present results and derive recommendations
- Interface with other sites and/or global functions to promote local solutions globally

**What you bring to Takeda**:

- HTL (Higher Technical College) with a focus on Bioinformatics, Information Technology or Biomedical Analytics, or
- Bachelor’s degree in Bioinformatics, Information Technology, Data and digital sciences, computational biology, bioengineering, or related field (Master´s degree is an advantage)
- Relevant professional experience is an advantage
- Physical ability to handle laboratory equipment

**_ Preferred:_**:

- Additional qualifications (e.g., Quality Management, GMP courses, LIMS training, Data Science certificates)
- Programming and data processing platforms (e.g. Databricks)
- Several years of professional experience in laboratory environments, analytics, or IT-supported quality management
- Knowledge of computer sciences and IT-infrastructure
- Data analysis skills
- Experience with laboratory software (e.g., LIMS)
- Familiarity with GxP (Good Practice) environments

**What we offer you**:
A competitive remuneration package with a minimum salary of € 3.395,16 gross per month (full-time, collective wage agreement for the chemical industry) - the actual salary is higher and depends on your professional experience and qualifications.
- Family-friendly company environment; support with parental leave, dad month, Bilingual company kindergarten
- Commuting allowance or parking space (tax applicable)
- Comprehensive training programs
- In-house job rotation program
- In-house Canteen with discounts or meal vouchers
- Works council (events, festivals, shopping vouchers, etc.)
- Employee Referral Program
- Employee Recognition Program
- Takeda Resource Groups
- Medical checkups
- Free vaccination program
- Employee discounts
- Employee Stock Purchase Plan
- Group accident insurance

**Mor