MIRWAIS RAZAWI

Decommissioning SME of Manufacturing, Abbvie, Campbell, CA

• Review quality plan to execute decommissioning activities
  Execute decommissioning of manufacturing equipment such as Fermenters, Biosafety cabinets, Filter Integrity Testers, TFF and others.
• Communicate with management, SMEs, and QA to ensure executions completes as expected

Process Engineer, Boehringer Ingelheim, Fremont , CA

• Execute PQ and IQ protocols
• Assemble and organize TOPs for pilot plant systems
• Participate in commissioning and execution plan meetings

Process Engineering Support, BioMarin, Novato, CA

• Adaptable and proficient in learning new concepts quickly and efficiently.
• Change Description and Change Plan generation.
• Coordination of vendors for onsite execution and facilities modification
• Process Engineering lead for upstream equipment and coordinate with contractors and vendors for facility and equipment support
• Managed third-party vendors, inspecting completed work and ongoing efforts to confirm quality and adherence to prescribed guidelines.
• Walkdown, redline and review and submit P&IDs
• Wet test equipment to ensure fit for use
• Review and check TOP submissions
• Calibrate with MBO and Calibration teams to implement newly purchased equipment systems and positions through CMMS
• Write Design traceability matrix for newly purchased process equipment
• Review Engineering documentation such as FAT, SAT, sSAT protocols to prepare for C&Q and Validation activities.
• Assist C&Q team to review and correct discrepancies
• Provide support for upstream equipment implementation for new projects like putting in work orders, ordering additional parts and tags and checking calibration status.

• Developed documentation, including diagrams and specifications, to meet project requirements and regulatory standards.
• Established project schedules and monitored tasks to meet milestones during each phase.
• Maintained exemplary conduct at all times, whether onsite or at client's facility.
• Managed third-party contractors, inspecting completed work and ongoing efforts to confirm quality and adherence to prescribed guidelines.
• Prepared scope of work documentation for use in budgeting and project planning efforts.
• Created process simulations to test operational outcomes without inducing service disruptions.
• Provided technical assistance to manufacturing associate when issues arose.
• Developed conceptual scope analyses of project objectives directly and via third-party contractor input.

• Work with team to allocate daily tasks and processes
• Participate in Kaizen meeting to improve processes
• Communicate Quality Assurance and Document Control Teams to ensure smooth processes
• Help engineering teams to validate equipment for process, provide support to engineering teams when necessary
• Use ATKAeady system to run purifications processes run various purification processes including MabSelect PuRe Lx, VRF and UF/DF Follow cGMP and GDP on all processes
• Participate in CAPA discussions when deviations occur
• Operate Unicorn Software to run purification processes
• Formulate Buffers for use in purification processes
• Read and Follow SOPs using SAP Read, Fill Out and Review Batch Records.
• Inspected products and machines to maintain quality and efficiency.
• Supported machine operators in setup and operation of production equipment resulting in efficient runs.
• Organized work to meet demanding production goals.
• Examined incoming materials and compared to documentation for accuracy and quality.

• Report to School Requesting Teacher in need for the district.
• Follow lesson plans left by teacher requesting substitute Help students with educational needs.
• Took over class for regular classroom teacher, managing assignments, student needs and recordkeeping.
• Kept students on-task with proactive behavior modification and positive reinforcement strategies.