Ron M. Holden
Wendell,NC
Summary
Top performing Bio-process Technician with 11 years of Biotechnology/ Injectable and Solid Dose manufacturing experience. Meticulous, hardworking, analytical, adaptive person, with strong ability to thrive in fast-paced manufacturing setting. The ability to effectively communicate issues and find root causes during troubleshooting. Comprehensive understanding of safety protocols, industry processes and quality control processes, coupled with ability in operating manufacturing equipment and tools.
Overview
28
28
years of professional experience
1
1
Certification
Work History
Manufacturing Associate IV
Biogen
01.2020 - Current
- Essential member of Large-Scale Manufacturing (LSM) Cell Culture Team
- Performs and documents daily manufacturing operations in a cGMP environment that involves process equipment such as Bioreactors (60L-3750L), Delta V, Filler integrity Testers, Vi-Cells, Parts Washers, Autoclaves, etc
- Perform routine execution of engineering and validation protocols
- Performs routine cycle counts of Kanban for Cell Culture area
- Creates/revises cGMP documents and other assignments
- Organized work to meet demanding production goals.
- Upheld clean and organized workspaces to promote efficiency and minimize the risk of accidents or contamination.
- Developed strong working relationships with colleagues, fostering a positive team environment that facilitated open communication and collaboration on projects.
- Exceeded daily production targets with consistent attention to detail and commitment to meeting deadlines.
- Participated in regular team meetings to discuss progress, address challenges, and align on strategies for achieving production goals.
Owner
K&J Landscaping and Lawn Care
01.1997 - Current
- Provide all aspects of lawn care and maintenance, including seeding, manicuring, planting, aerating, pruning, and irrigation
- Provide handyman services, both major and minor
- Provide painting, light fixture installation, carpet/flooring installation and fence repair
- Mechanically inclined to repair most issues around home or office
- Managed day-to-day business operations.
- Developed and maintained strong relationships with clients, resulting in repeat business and referrals.
- Increased customer satisfaction by implementing efficient business processes and providing exceptional service.
Bio-process Technician
Merck Durham Plant
01.2014 - 01.2019
- Subject Matter Expert (SME) for multiple sub-suites pertaining to Cell Culture, including Cell Plant, Refeed, Seed Production Bottle (SPB), Harvest Working Seed (HWS), Harvest Production Bottle (HPB)
- Fully trained in all Robotic sub-suites, performing and documenting daily manufacturing operations in a cGMP environment
- Extensive knowledge and experience with Environmental Monitoring, EBR, MES, PMS, automated systems, Delta V, and SAP
- Designated trainer for new hires and existing personnel
- Stayed compliant/current on all relevant SOPs
- Maintained Aseptic Qualifications and received numerous awards for aseptic processing within cGMP environments
Bio-Process Technician
Spectaforce Technologies Inc
01.2013 - 01.2014
- Worked as a contractor for Merck Durham within the Cell Culture/Virus Suites
- Duties included monitoring processes, recording results, and documenting data necessary for the accountability and tracking of product
- Operated Robotic set-ups, processes, and breakdown of processes
- Provided maintenance, support, and equipment preparation for vaccine production
- Maintained a safe work environment by strictly adhering to established safety protocols and guidelines.
- Trained new technicians on standard operating procedures, ensuring consistency across the team.
Operator
Kelly Services
01.2005 - 01.2008
- Worked as a contractor for GlaxoSmithKline(GSK)
- Duties included the operation of Solid Dose equipment such as Thermoformers, In processing, Cartoner, Case Operator of Lasko Omega Bottle Unscrambler
- Solid Dose manufacturing and packaging
- Assembled and disassembled Solid Dose manufacturing lines before and after production
- Operated various types of machinery, demonstrating versatility and adaptability in diverse work environments.
Education
Diploma -
East Wake High School
Wendell, NCCertificate of Completion - Telecommunications
Central Carolina Community College
Sanford, NCSkills
- Assembly line experience
- Adaptable learner
- Machine operation
- Stress tolerance
- Attention to detail
- Teamwork and communication
- Strong work ethic
Certification
- Certified in Batch Record Review
- Certified in Helium Can Testing
Timeline
Manufacturing Associate IV
Biogen
01.2020 - Current
Bio-process Technician
Merck Durham Plant
01.2014 - 01.2019
Bio-Process Technician
Spectaforce Technologies Inc
01.2013 - 01.2014
Operator
Kelly Services
01.2005 - 01.2008
Owner
K&J Landscaping and Lawn Care
01.1997 - Current
Diploma -
East Wake High School
Certificate of Completion - Telecommunications
Central Carolina Community College
- Certified in Batch Record Review
- Certified in Helium Can Testing
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