..Pfizer Manufacturing Specialist, Downstream (1st Shift) in Bothell, United States Why Patients Need YouOur breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes.You will help to ensure that patients and physicians have the medicines they need,when they need them.What You Will AchieveThe North Creek Manufacturing Facility at Pfizer is seeking a highly motivated Manufacturing Specialist that desires the opportunity to significantly contribute to the development and commercialization of transformative cancer therapies. The Manufacturing Specialist will use their training and knowledge of biopharmaceutical manufacturing to execute operations in a cGMP Facility.How You Will Achieve ItPerform oversight of process operations and monitor equipment and critical process parameters. Utilize production experience to articulate any production issues or abnormalities to management and other cross functional groups. Provide insight and recommendations to address production issues leading the execution of any non-routine or troubleshooting activities. Taking a proactive approach to identify and address potential issues prior to their occurrence.Successfully represent your function group with regard to production operations and associated equipment/procedures during audits/inspections or at cross functional team meetings.Create and revise SOPs (standard operating procedures) and MBRs (master batch records)as appropriate.Participate in investigations of safety or quality issues as necessary.Author investigations for deviations related to processing operations ensuring timely and complete documentation.Perform activities related to qualification, commissioning, and decommissioning of equipment and completes documentation for change controls as necessary.Lead or assist with scheduling and execution of production tasks including campaign startup and product changeover. Coordinate communication with cross functional partners and management regarding production updates and issues affecting the production schedule.Utilize standard operating procedures and documents cGMP activities within batch records and logbooks applying good cGMP documentation and data integrity practices.Complete setup, use, and cleaning (as necessary)of cGMP production equipment.Proactively work to achieve training competency in production operations.Lead training of other inexperienced associates and is a system matter expert and qualified trainer for relevant equipment and procedures. Develop, review, and modify training content as necessary to build and maintain a comprehensive training program. Help inexperienced associates understand cGMP documentation practices #J-18808-Ljbffr
