Neil Robinson
Project Leader at Performance Validation- Claim this Profile
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Topline Score
Bio
Credentials
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Basics of Laboratory Safety
AIChE - American Institute of Chemical EngineersFeb, 2016- Nov, 2024 -
Process Safety 101
AIChE - American Institute of Chemical EngineersFeb, 2016- Nov, 2024 -
Safety in the Chemical Process Industries
AIChE - American Institute of Chemical EngineersFeb, 2016- Nov, 2024 -
Aseptic Processing Area Gowning Qualified
FDANov, 2018- Nov, 2024
Experience
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Performance Validation
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United States
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Project Leader
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May 2022 - Present
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Validation Engineer
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Apr 2019 - Present
• Apply industry, regulatory and client specific knowledge to develop typical validation life-cycle documents including but not limited to Design Review/Qualification; Risk Assessment; Receipt Verification; Installation Qualification; Operational Qualification; Performance Qualification; Requalification Validation; Process Validation; and associated Reports.• Apply good documentation practices in execution of protocols, procedures, and other cGMP documents.• Perform Commissioning and Qualification or Verification/Validation activities, including but not limited to: execution of Receipt Verification, Installation Qualification; Operational Qualification; Performance Qualification; and Requalification.• Assist in the development of concise acceptance criteria for an operational test or inspection. Reviewing data to determine compliance with acceptance criteria.
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Grand River Aseptic Manufacturing
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United States
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Aseptic Manufacturing Associate
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Aug 2018 - Mar 2019
• Prepared equipment and formulated active pharmaceutical ingredients to be filled into vials• Utilized a vial washer, oven, autoclave, and lyophilization equipment in the process of preparing product and vials for an aseptic processing area• Recorded data in compliance with cGMP, GDP, and SOP practices• Qualified and worked in an aseptic production area • Prepared equipment and formulated active pharmaceutical ingredients to be filled into vials• Utilized a vial washer, oven, autoclave, and lyophilization equipment in the process of preparing product and vials for an aseptic processing area• Recorded data in compliance with cGMP, GDP, and SOP practices• Qualified and worked in an aseptic production area
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Michigan State University
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United States
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Higher Education
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700 & Above Employee
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Resident Assistant
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Aug 2013 - Jun 2018
• Advise approximately 50 residents each semester while developing interpersonal connections on the floor• Mediate issues between residents while demonstrating proper conflict resolution tactics• Respond to crises within the residence halls to address emergency situations and enforce departmental protocol to ensure the safety and security of residents• Identify and report issues such as student mental health concerns, inappropriate behavior, and facilities issues while providing support to affected students• Collaborate with coworkers to develop team-led initiatives for programming and initiate educational opportunities within the hall
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Central Service Center Representative Supervisor
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Apr 2015 - May 2018
• Directly supervised 100 Level I Service Center Representatives who would maintain safety and security, distribute mail to residents, and delegate facilities concerns within the residence halls • Collaborated with other Level III Supervisors to complete weekly tasks, improve communication, and increase the engagement of Level I Service Center Representatives• Revised departmental policies and procedures to reduce the size of archives by implementing technological storage protocols and eliminate inefficient time expenditures
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Education
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Michigan State University
Bachelor's degree, Chemical Engineering