Key skills
Communication
About this role
Role Overview
- Work with key stakeholders to evaluate new and existing technologies
- Develop design documents based on platform process requirements
- Assist project leads and automation team with integrating equipment and technologies
- Evaluate single-use technologies and design single-use manifolds and assemblies
- Work with vendors to develop data and validation packages supporting technologies
- Facilitate procurement and implementation of approved new technologies
- Develop business processes, guidelines, SOPs, and training for processing equipment and technologies
- Lead the development equipment maintenance & life cycle plans
- Partner with Site MSAT Manufacturing Technology & Science teams
- Participate in non-conformance/deviation investigation
Requirements
- BS in engineering, sciences, or related life science engineering
- 2-5 years of relevant experience in Pharmaceutical, Biotech, or Life Sciences industries, or an MS degree
- Working knowledge of cGMP manufacturing and regulatory regulations
- Solid understanding of monoclonal antibody processing
- Experience working with single-use disposable manufacturing systems
- Demonstrated ability to work independently and collaboratively on cross-functional teams
- Working knowledge of manufacturing process equipment and automation systems
- Ability to organize, analyze/interpret, and effectively communicate process data
- Excellent oral and written communication skills
Benefits
- discretionary annual bonus
- comprehensive benefits to include Medical, Dental and Vision
- short-term and long-term disability
- company paid basic life insurance
- 401k company match
- flexible work
- generous paid time off
- paid holiday
- wellness and transportation benefits