- Conceives, plans and conducts independent qualification/validation work or project work from inception through product launch and field support, defining schedules, and applying qualification or validation strategy that is robust and agile complete projects.
- Perform equipment Installation, Operational, and Performance Qualifications on a variety of facility, clean utilities, manufacturing process equipment, and analytical testing equipment in a full Biotech upstream/downstream manufacturing plant. Qualification includes conception of qualification assessments, protocols, authoring protocols, execution, and final report writing.
- Participates and leads project planning, qualification/validation scheduling, process updates, and experimental design. Assumes responsibility for timely completion of projects or assigned work, ensuring activities are consistent with project critical path and responding appropriately to changing priorities.
- Ensures technical activities under delegated supervision are conducted within internal and external guidelines and regulations (including QSR and FDA regulations). Interacts and collaborates with other departments to further project goals.
- Documents equipment/facility/utility qualification activities accurately and appropriately, and according to established formats and procedures.
- Serves as an expert resource to other departments Manufacturing/Operations, Development, Quality, Marketing, Regulatory Affairs, and Technical Services), provides timely response and follow-ups.
- Participates in the expeditious transfer of products and technologies by providing scientific knowledge and assistance. Provides technical advice/guidance to junior scientific staff, leads project teams to solve business problems of moderate size risk and complexity and serves as an overall role model.
- May interact on a project budget, but generally budget oversight belongs to a higher level manager.
- May represent RMD as primary
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Manufacturing Equipment Validation Specialist/Engineer - Branchburg, United States - Roche
Description
The Position
At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity. We believe every employee makes a difference. We are passionate about transforming patients' lives. We are courageous in both decision and action; we believe that good business means a better world.
Job Summary
