Sterility Assurance Specialist

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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.

Sterility Assurance Leadership:

• Act as the Quality Representative for Sterility Assurance and lead of the Contamination Control Strategy within QC Orth.

• Oversee the Environmental Monitoring (EM) program for classified areas, ensuring robust sampling plans, trending, and deviation management.

• Supervise cleaning and disinfection programs, including validation of disinfectants and rotation strategies.

• Define and monitor gowning procedures, hygiene behavior, and personnel practices in aseptic areas.

• Ensure compliance with aseptic techniques and contamination control strategies in laboratory operations.

• Develop and implement annual sterility assurance training programs for all Orth employees.

• Manage the pest control system for cleanroom zones, ensuring proactive and compliant measures.

• Support Quality Validation of cleanroom environments, classified objects and microbiological analytical methods.

• Lead EM Risk Assessments and Performance Qualifications (PQ) for cleanroom environments and classified objects.

• Evaluate microbiological and sterility requirements for materials and consumables used in QC laboratories.

• Serve as Super User for the Laboratory Information Management System (LIMS), supporting sterility-related data integrity and workflows.

Cross-Functional Quality Responsibilities:

• Design, implement, and continuously improve GMP standards and quality guidelines across supported departments.

• Lead and contribute to cross-functional projects, including facility upgrades, equipment qualification, and process improvements.

• Stay current with internal and external regulatory requirements, guidelines (e.g., EU GMP Annex 1, ISO standards), and industry best practices; ensure timely implementation.

• Act as a key contact for quality system applicability, supporting audits, inspections, and internal assessments.

• Review departmental workflows to ensure adherence to QA and GMP requirements, including documentation, deviation handling, and CAPA management.

• Degree in Microbiology, Pharmacy, Biotechnology, or related life sciences field.

• Proven experience in sterility assurance, aseptic processing, or microbiological quality control in a GMP-regulated environment.

• Strong knowledge of EU GMP Annex 1, ISO cleanroom standards, and contamination control principles.

• Experience with LIMS systems, EM data trending, and risk-based approaches to sterility assurance.

• Excellent communication and training skills.

• Ability to work cross-functionally and manage multiple priorities

Preferred:

• Work experience in quality assurance function and experience in implementation of GMP requirements are beneficial

Key Skills, Abilities, and Competencies

Living our Ieadership behaviors is a basic expectation for all Takeda employees. Takeda expects all employees to embody the following: Be positive; be accountable; be results oriented; be an excellent manager of self and others.

• Biotechnological and technical understanding

• Excellent communication and team skills

• Very good knowledge of English and IT

• Organized and structured way of working

• Independent, proactive, and solution-oriented working style

• Analytical and cross-departmental thinking

• Assertiveness

A competitive remuneration package with a minimum salary of € 4.270,14 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.

• Short term incentive program (Bonus)

• In-house Canteen with discounts or meal vouchers

• Commuting allowance or parking space (tax applicable) 

• Family-friendly company environment; support with parental leave, dad month

• Comprehensive training programs

• In-house job rotation program

• 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 

Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide. Our passion and pursuit of potentially life-changing treatments for patients are deeply rooted in over 240 years of distinguished history in Japan.

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.

For over 240 years, Takeda's propensity to evolve has driven the next generation of innovation. Today, the organization spans the globe—colleagues across business units and functions face challenges head-on to deliver on our vision. The omnipresent patient focus instills pride in personal contributions.

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. 

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