Benjamin Blanchette Email & Phone Number

Chicago, Il, Us

Melbourne, Victoria, Au

Melbourne, Victoria, Au

Act as C&Q lead on operational and capital projects ranging from $50,000 to $500,000Defend qualification strategies during external audits. Provide oversight for contractors including acquiring quotes, defining Scope of Work, onboarding, and technical assistance Plans, communicates, and leads scientifically sound qualification strategies for qualification projects for all phases, Commissioning, Initial Qualification, Operational Qualification, and Performance Qualification Perform assessments on Global Change Controls to assess potential impact to Commissioning and Qualification activitiesSupports CAPA activities: o Including: SOP updates, FDA and other regulatory bodies response, improvements to current product lines, and changes to equipmentPrepares detailed, concise reports on completed studies that summarize the test results and their conformance to defined acceptance criteria in a timely mannerEffectively communicates with appropriate functional groups (i.e. Manufacturing, Engineering, and QC Labs, etc.) in regards to the needs and status of assigned study execution activitiesRecognizes and trouble shoots problems associated with qualification studies, equipment, and proceduresProvides technical support other functional groups (i.e. Manufacturing, Engineering, QC Labs, etc.) as neededFoster a culture of continuous improvement and qualityProvides technical support/training to Validation department personnel in areas of competencySubject Matter Expert (SME) for Mixing Validation for CSL Kankakee Site

Melbourne, Victoria, Au

Responsible for testing systems (equipment, facilities, and processes) used to develop or manufacture products in a cGMP environment Plans, communicates, and leads scientifically sound validation strategies for validation projects for all phases: Commissioning, Initial Qualification, Operational Qualification, and Performance Qualification Prepares validation protocols and test equipment for execution Supports CAPA activities: Including: SOP updates, FDA and other regulatory bodies responses, improvements to current product lines, and changes to equipment Collects and evaluates validation test data for conformance to protocol acceptance criteria and/or to investigate and determine root cause of validation study discrepancies Prepares detailed, concise reports on completed studies that summarize the test results and their conformance to defined acceptance criteria in a timely manner Selected to take part in a month long commissioning, initial qualification, operational qualification, and performance qualification of a CSL Behring R&D site in Pasadena, California Effectively communicates with appropriate functional groups (i.e. Manufacturing, Engineering, and QC Labs, etc.) in regards to the needs and status of assigned study execution activities Recognizes and trouble shoots problems associated with validation studies, equipment, and procedures Assists with technical support/training to Validation department personnel in areas of competency Provides technical support other functional groups (i.e. Manufacturing, Engineering, QC Labs, etc.) as needed Foster a culture of continuous improvement and quality

Milwaukee, Wi, Us

Utilized leadership skills to act as a mentor and advisor for a University wing of 25-35 diverse undergraduate students Created, planned, and implemented educational and social programs to build community among residents and promote diversity Developed collaboration and conflict resolution skills by de-escalating conflict between roommates by mediating conversations regarding behavior and lifestyle differences

Sturtevant, Wi, Us

Performed general maintenance and repairs on products Worked on research and development projects: Developed a proof of concept for an OLED display on a hair clipper Created the electrical system of a prototype cordless hair dryer Ensured that products met safety standards (As established by Underwriter Laboratories) by performing tests including but not limited to: current, voltage, and leakage current Collaborated with other Product Engineers, Quality Engineers, and Manufacturing Engineers on cross-functional project teams

Melbourne, Victoria, Au

Assisted and shadowed validation teams during various validation studiesReviewed validation calculation documents

Master Of Science - Ms, Quality Engineering And Management

Bachelor Of Science (B.S.), Biomedical/Medical Engineering