Project Engineer – Joule Clinical Staffing – Alameda County, CA, USA
- BS with 6+ years relevant experience, or MS with 4+ years relevant experience
- Several years of project management and technical experience in production or CMC development of (bio-) pharmaceutical products in international (bio-) pharmaceutical industry
- Previous experience with manufacturing process technology for (bio-) pharmaceutical products is strongly preferred.
- Knowledge of the methods and tools of project management.
The purpose of this position is to support the Operations Manager in translation of business needs into a project approach; defining, documenting and implementing the project execution plan. Manages assigned elements of a project in all project phases (Design, Procurement, Development, Commissioning, and Qualification) to ensure robust, reliable, compliant, and cost efficient process.
- Interface to internal partners (Production, Validation, Supply Chain Management, and Quality) and external partners (CMOs).
- Manage Cold Chain distribution projects including thermal packaging design, development, and implementation.
- Selection and specification of new equipment. Coordinate installation, commissioning, and qualification activities.
- Coordinate and manage process development and validation activities.
- Act as Project Manager and technical expert in cross-functional Cold Chain team.
- Responsible for timely completion of assigned project tasks; Ensures own work is properly coordinated with the activities of others, as necessary to complete a project.
1. Work closely with all relevant functions to ensure smooth implementation.
2. Create and maintaining project plans and project tracking reports.
3. Schedule and chair project team meetings.
4. Capture meeting minutes, decisions and action logs.
5. Communicate project progress and escalate barriers.
Location: Berkeley, CA