KEY RESPONSIBILITIES: (10 bullet points maximum)
- Provide engineering support for the design, testing and optimization of biopharmaceutical manufacturing equipment up to 20,000L scale including stainless and single-use bioreactors, centrifuges, chromatography systems, filtration skids, pasteurizers, chromatography skids, etc.
- Manage capital projects and engineer solutions involving retrofits, modifications and acquisition of process equipment.
- Support execution of technology transfer and scale-up activities.
- Lead resolution of technical issues with manufacturing operations and equipment.
- Collaborates with other manufacturing support groups including Validation, Automation, Quality, Metrology, Maintenance and Process Development.
- Applies knowledge of process and utility systems to make recommendations to improve manufacturing systems, equipment and process efficiencies.
- Experience with project management (schedule, cost, communications) and coordination of internal and external resources to execute projects in a timely and cost-effective manner.
- Subject matter expert (SME) and equipment owner for Upstream and/or Downstream process equipment with ability to assist in the execution of design, procurement, testing (FAT, SAT, commissioning), installation and validation activities.
- Capable of negotiating contracts, bids, and change orders with vendors or contractors.
- Support investigations and recommend solutions with key stakeholders in order to gain a consensus on effective corrective and preventive actions (CAPA)
