Biopharma Manufacturing & Equipment Maintenance Specialist
Resume:
Tyrone Hawkins
Henderson, NC ***** +1-252-***-**** **************@*****.***
Professional Summary
Experienced in Biotechnology, and Pharmaceutical Industries, and HMI Production Line Operation and Maintenance.
● I am able to troubleshoot, and maintenance production equipment.
● Competent in Biotechnology production processes as well as pre, and post Lab-work.
● Computer literate.
● Served as Shift Training Coordinator.
● Completed Fundamentals of Biomanufacturing
● Completed Bioworks.
● Certificate Aseptic Processing.
● Shift Safety Representative.
● Can Execute Validation Protocols.
● Accessing Samples.
Work Experience
Manufacturing Specialist II
Medicago USA, Inc. Pharmaceutical Company Durham, NC January 2022 to December 2023
● Operation and Cleaning of TFF-1 skid.
● Planned designed set-up modified optimized and monitored the manufacturing process.
● Responsible for inspection, maintenance and repair of equipment.
● Coordinated with engineers to ensure all product and system requirements were implemented.
● Understanding of cGMP compliant production and documentation.
● Assisted and supported in the process scale-up, process optimization and process validation activities.
● Adhering to and development of documentation, including standard operating procedures and batch records.
● Duties also included checking and weighing raw materials, ensuring that machine settings are correct, maintaining a clean production environment, running quality checks on the size and weight of the finished product, assembling, packaging and labeling.
Operator Technician
REVLON, INC. Oxford, NC
January 2019 to December 2022
● Have Independently operated production lines; making technical decisions impacting safety, quality and financial Key Performance Indicators (KPIs).
● Operated equipment in accordance with Safety, Quality, cGMP and Standard Work guidelines.
● Conducted in-process quality checks; taken necessary actions for non-compliance.
● Conducted changeover activities per daily schedule to include: geometric, shade and cleaning and sanitization. Continuously improved the process.
● Ensure 5S standards are achieved for equipment and line area.
● Complete root cause problem solving and action planning as required
● Take ownership of KPIs and process, drive improvement within, and coordinate activities within/across line teams
● Actively eliminate Lean (8 forms) waste; develop standard work instructions and OPLs as required
● Conduct systematic troubleshooting and basic maintenance on packaging lines to maximize uptime.
● Complete all documentation required.
● Ability to coach/train other employees.
● Ability to work in a team-based environment (shared ownership and responsibility).
● Ability to take ownership of critical KPIs and develop action plans to improve.
● Ability to understand Statistical Process Control - translating product specifications to finished goods. Technician / Cell/Media
Merck & Co., Inc. Durham, NC
January 2012 to December 2019
● Trained in assembly, equipment wash area, decontamination, and decontamination autoclaves, also GMP dry heat ovens, and GMP autoclaves.
● Functioned as Subject Matter Expert in assembly.
● Shift Safety Representative.
● Fully trained in Media formulations, Cell Culture proliferation. Thaw component closures.
● Over five years of experience in the Merck Operations Division,
● Manufacturing experience in Varicella utilizing SAP in a manufacturing setting.
● Demonstrated use of Electronic Batch Records.
● Able to demonstrate strong leadership Skills.
● SME in current Process/Sub-Suite, Thaw.
● Strong knowledge base of multiple areas and multiple systems.
● Ability to work independently and drives projects to solution
● Current (C) shift Safety Representative.
● Completed Operations Mechanical Technician, Technical Training, Levels 1, 2, and 3.
● Promoted to Technician in Cell/Media in 2016.
● Accessioning of Samples.
● K-Flex USA LLC, Youngsville, N.C.
● Lab Technician / Machine Operator / Quality Assurance
● 2010 – 2012
● Operates Rheometer, and Tech-Pro for the analysis of milled rubber, for the manufacture of Industrial, and residential Insulation. Reads pressure curves, and multi curves in order to notify Oven operator and Banbury operator if there are any problems with the rubber.
● Accessioning of Samples.
Materials Resource Technician
Duke University Medical Center Durham, NC
January 2009 to December 2010
● Responsible for decontamination, operation of steam, ETO and other forms of sterilization as well as all monitoring processes included with the same, and assemble surgical instruments. Ensure accuracy of the inventory within the material services storeroom, and or the Records Retention Warehouse. Prepare and assist in cycle count verifications and annual inventory; stock linen. Performed duties in computerized order entry.
Manufacturing Associate, Cell Culture.
Biogen Idec Research Triangle Park, NC
January 1998 to December 2008
● Performed equipment preparation operations, and manufacturing unit operations of biopharmaceutical products. Duties included inoculum preparation, bioreactor operation
(100L, 750L, 2000L scales), and Microfiltration downstream purification, CIP unit operations and related production. Performed documentation of daily manufacturing operations, and implemented new ideas to improve cGMP (Current Good Manufacturing Practices), in an environment that involves operation of various process equipment, execution of validation protocols; created / revised cGMP documents and other assignments as necessary.
● Accessioning of Samples.
Education
Fundamentals (Certificate of Completion)
Biomanufacturing NC State University
September 2020
High School Diploma
Sr. High School
Certificate
Wake Technical Community College in Bioworks Raleigh, NC Time Management
Harvard
Logistics Vance Granville Community College
Aseptic Processing (Certificate)
Capstone Learning Center, North Carolina State Raleigh, NC Skills
Data collection Engineering technician experience Production documentation Manufacturing Assembly drawings Mechanical assembly Risk management Driving Filing Analysis skills Languages
English
Certifications and Licenses
Driver's License
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