Sterility Assurance Specialist – m/f/d
Takeda
full-time
Posted on:
Location Type: Hybrid
Location: Orth an der Donau • 🇦🇹 Austria
Visit company websiteSalary
💰 €4,270 per month
Job Level
Mid-LevelSenior
About the role
- Ensure compliance with required hygiene standards (e.g., through process observations, accompanying media fills, hygiene walkthroughs, employee clearances…)
- Create and review specifications (in accordance with regulatory requirements and internal policies) related to aseptic operations
- Actively serve as the Quality Representative for sterility assurance
- Monitor Environmental Monitoring (EM) for classified areas; ensure robust sampling plans, perform trend analyses and manage deviations
- Lead and coordinate change control projects in pharmaceutical manufacturing
- Oversee cleaning and disinfection programs, including validation of disinfectants and rotation strategies
- Define and monitor gowning requirements, hygiene behavior and personnel practices in aseptic areas
- Ensure adherence to aseptic techniques and contamination control strategies in laboratory operations
- Evaluate microbiological and sterility requirements for materials used in QC laboratories
- Continuously improve GMP standards and quality policies across all supported departments
- Lead cross-functional projects for facility modernization, equipment qualification and process improvements
Requirements
- Completed scientific education (degree, college, technical school) in Chemistry, Biology, Pharmacy or a related field
- Experience with particulate contamination in products (e.g., through handling deviations in this area, process knowledge, etc.) is an advantage
- Solid professional experience in a pharmaceutical environment in microbiology (e.g., handling or assessment of microbiological deviations)
- Ability to work cross-functionally and manage multiple priorities
- Experience with LIMS systems
- Very good German and English skills (for regulatory audits) and excellent communication skills
- Independent working style, team orientation, flexibility and a strong sense of responsibility
Benefits
- Certified family-friendly company (comprehensive re‑entry programs after parental leave)
- Hybrid working & flexible scheduling where possible
- Training and development opportunities
- Comprehensive training programs, personal development and mentoring
- Internal job rotations domestically and internationally
- Employee referral and recognition programs
- Active participation in network groups on various topics (e.g., Diversity, Equity & Inclusion, Sustainability)
- Diverse health and fitness offerings
- Free vaccinations and psychological counseling
- Company events & celebrations
- Works council
- Company cafeteria at subsidized prices
- Bilingual company kindergarten / on-site childcare
- Good public transport connections
- In-house fitness & wellness center
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
aseptic operationsmicrobiologyGMP standardsenvironmental monitoringcontamination controlcleaning and disinfection validationtrend analysischange controlspecification reviewparticulate contamination
Soft skills
communication skillsteam orientationindependent workingflexibilitysense of responsibilitycross-functional collaborationability to manage priorities