Our client is looking for a Global Aseptic Support consultant with 10+ year of experience for a 12 month assignment who can provide global leadership and guidance on aseptic manufacturing for Bio and Pharma products for their Internal and External manufacturing network. In this role the Global Aseptic Support consultant will act as a subject matter expert on areas of aseptic manufacturing, sterilization technology, sterile systems validation, microbiology, bio-processing, aseptic and non-aseptic processing, design and management. This role will also play a key role with providing support for internal and/or external sites and due diligence efforts in support of business development activities. Strong on Annex 1 Experience required. Must be based in Eastern or Central time zones to accommodation the client’s EU relations.
- Provides support and resources in Microbiology, Aseptic Process, Non-Aseptic Processing, and related areas needed for scientific and technical projects.
- Participates in internal and external quality assurance assessments of pharma and biological product manufacturing operations, bio-processing facilities, bio-analytical laboratories, and in the assessments of contract operations that supply sterile and nonsterile drug products and drug and biological products.
- Applies advanced in-depth technical and industry-specific principles, theories, concepts. Contributes to new principles and concepts.
- Develops and manages an aseptic risk assessment tool, identify risk area, report to leadership and propose improvements
- Develops training materials on aseptic practices and behaviors and deliver training
- Leads global aseptic network with site representative driving best practices and implementation of required aseptic processes SMEs for standards.
- Provides guidance and support for strategic decisions pertaining to aseptic technology for Pharma and Bio platform
- Lead special projects as required by customer and group needs and provides support as needed to GMS programs
BS degree in Microbiology, Pharmacy or Bio Science Engineering
Remote: Global Aseptic Support Consultant (233813)