The person in this position has to function as a network owner and support for processes related to Microbiology (e.g., Microbiological Method Validations), Microbial Contamination Control, Aseptic Processes/Sterility Assurance/Cleanroom Behavior topics by setting and driving standards through global procedures and guidance documents. Thereby Quality by Design (QbD) and Continuous Improvement approaches are utilized. Additionally, this position provides remote as well as on-site support in case of contamination events, and assists as Subject Matter Expert during internal as well as external CMOs (Contract Manufacturing Organization) audits.
Essential Duties and Responsibilities:
- Develop and/or own microbiological relevant documents, such as global procedures, (e.g. Microbiological Process Simulation) and tools
- Own and harmonize contamination control related processes and documents
- Develop position papers as needed, e.g., for explaining why a manipulation is done/not done in a particular way, etc.
- Define microbiological specifications for raw materials
- Provide input and/or define process steps (for new products) at which microbiological quality control samples need to be taken/tested
- Benchmark and harmonize best practices throughout Shire
- Facilitate and/or support knowledge sharing throughout Shire, e.g., lessons learned
- Support and lead the Global Micro Alliance Work Group
- Lead and/or support cross-functional contamination investigations
- Organize and lead relevant (e.g., in case of contaminations) global teleconferences/webex calls within Shire as well as with external stakeholders
- Develop templates for microbiological method validations/reports and review and approve them - once populated
- Evaluate rapid micro methods and build a business case for implementation
- Provide guidance regarding laboratory infrastructure and design/re-design, as well as on design/re-design of manufacturing areas and/or equipment from a microbiological/contamination control aspects
- Benchmark with industry on relevant microbiological and aseptic/sterility assurance topics
- Serve as an SME (Subject Matter Expert) for performing and supporting internal and external (e.g., CMO audits)
- Support Regulatory Affairs, regarding microbiological/aseptic related questions from health authorities
- Support facilities in the course of responding to observations from health authorities
- Serve as SME for microbiological/aseptic/cleanroom behavior related topics at CMOs/CTLs
- Participate with external platforms and organizations, such as e.g., BPOG, the Austrian Microbiology Pharma Cercle, etc.
- Experience in Microbiology Lab, Aseptic Practices and Techniques in a manufacturing setting
- Experience with Quality Systems preferable in a FDA and EMEA regulated manufacturing setting
- Thorough knowledge of applicable regulations, guidance documents, such as ISO 14644, ISO 9001, FDA Aseptic Guidance, EU GMP Guide, etc.
- Strong analytical and problem solving skills
- Ability to lead multi-facility teams
- Good communication, negotiation skills, and ability to lead multi-facility teams
- Excellent English skills
- Good presentation skills
- Ability to travel at times extensively, as needed
Education and/or Experience:
- BS in science or microbiology
- 7 years in Quality, Engineering, Manufacturing or related field
- 3 years management experience (such as supervising projects, leading work groups, etc.)
Company Insights https://youtu.be/ly_8oO-iJeU
Your application should include motivation letter and CV. Remuneration corresponds to the respective classification according to the collective agreement. The minimum salary for this position is € 3,065.25 gross per month (full-time). Increased payment is possible. In addition we offer many social benefits (e.g. canteen, wellness-center, company kindergarten) to mention just a few of them.
We offer outstanding opportunities to committed and talented people. Sex, age, color of skin, origin, ethnicity, sexual orientation as well as a physical handicap do not matter to us. On the contrary: We promote diversity in every field.