This position takes a role in identifying, gaining consensus and resolving issues of safety, compliance and efficiency that impact the FFIP (Formulation, Filling, Inspection and Packaging) Platform. The role contributes as a member of cross-functional teams to support the FFIP platform and functions as an interface between the FFIP platform and the Technical Community (especially Engineering/Maintenance and Manufacturing Technology).
- Individual contributor role that is member of cross-functional teams that provide support for the FFaST (Focus Factory and Support Team) efforts for the Factory.
- Provides project support for cross functional teams.
- Provides Factory interface for working through project issue.
- Provides technical support for the factory.
- Provides Continuous Improvement support for the factory.
- These are small/medium individual projects to improve OEE, Deviations, Yield, etc.
- This organization will provide project support to accomplish these efforts.
- These projects may be FFaST projects or managing Change Controls and CAPA’s for the production unit.
- Provides Project support. This group will be interface for technical transfers, engineering projects and similar activities.
- This group will provide support for the projects, especially for time intensive and major projects.
- Author documents and manage associated workflows.
- Ensure compliance with all regulatory requirements and good documentation practices are followed to provide a safe, quality, and effective product.
- This role will focus on documents and the client will teach them how to create / manage change controls.
- BS required in Life Sciences or Engineering.
- 2-5 years large scale biotech or pharmaceutical, manufacturing, maintenance, engineering, analytical & process development experience.
- Must have excellent written and verbal communication skills,
- Must have the ability to actively, and cooperatively work with cross functional teams.
- Must have excellent written and verbal communication skills, as well as the ability to actively, and cooperatively work with cross functional teams.
- **This will be a position on site at least 2-3 days a week