Senior Process Chemical Engineer
Direct Filling line Experience a must
Sterile Drug Product Unit
1 – 2 year contract
Provide process engineering services in support of the design, construction, commissioning and qualification of a Sterile Formulation and Filling Facility
- Minimum of 5 years post academic process engineering experience in relevant aseptic/sterile processing design, construction & start-up environment.
- Demonstrated ability to lead / influence teams in matrix environment
- In depth understanding of process engineering and technologies pertinent to unit operations including Closed-Process Formulation, Depyrogenation Tunnel, Isolated Filling, Capping, Automated Parts Washing, Autoclave Sterilization, Mobile Process Vessels, Bioburden reduction/Sterile Filtration, and CIP/SIP.
- Knowledge on the application of Disposable Technologies
- Knowledge of PLC process control platforms and industry SDLC methodology
- Support GES Process Lead to implement a Process Design based on the scope of Process Requirements provided by the Technology and Manufacturing owners.
- Lead cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables.
- Ensure all project stakeholders are informed and consulted on key process suite activities and decisions.
- Monitor progress of process suite team milestones with all team members and provide status reports to project Tiers and stakeholders.
- Act as client owner representative to self-execute critical design deliverables and provide direction & oversee design progression by an Architect & Engineering design firm.
- Develop Process Flow Diagrams, P&IDs, User Requirement Specifications and Equipment Specifications to ensure Process Descriptions/Needs are met.
Manage team to complete process safety deliverables including PHA (Hazops