Sterile Manufacturing / Biopharma Specialist Resume
Resume:
PROFESSIONAL SUMMARY
Accomplished manufacturing and biopharmaceutical professional with 10+ years of experience in sterile processing, electrical/mechanical assembly, and cleanroom operations. Proven ability to perform aseptic compounding (ISO 5/7/8), operate fill-finish equipment, lead team training, and maintain compliance with cGMP, GDP, and Lean manufacturing standards. Recognized for strong technical troubleshooting skills, root cause analysis, and a commitment to operational excellence and continuous improvement.
CERTIFICATIONS & TRAINING
Six Sigma Yellow Belt (2016)
Lean Manufacturing / Kaizen (2013–2018)
GDP, Cleanroom & Biosafety Cabinet Operations (2024)
Advanced Soldering & Crimping – Wake Tech (2018)
Reading Electrical Diagrams – Wake Tech (2018)
Arc Flash & Shock Safety (2018)
CDA, IDC, Quality & Label Operations (2020)
On-the-Job Trainer / Coordinator (2015–2020)
Safety, Wellness, Ergonomics, and Continuous Improvement Teams (2020)
Safety Training: Bloodborne Pathogens, Chemical Hazards, Hygiene, Evacuation (2024)
CORE COMPETENCIES
Cleanroom Sterile Manufacturing (ISO 5/7/8) & Aseptic Gowning
Fill-Finish Operations & Equipment Setup
Electrical & Mechanical Assembly
cGMP / GDP Compliance & Process Documentation
Root Cause Analysis & CAPA Support
Lean / 6S / Kaizen Implementation
Autoclaving & Material Preparation
Team Training, Coaching & Leadership
PROFESSIONAL EXPERIENCE
TomorrowMed Pharma – Morrisville, NC
Sterile Process Lead Operator 2024–Present
Perform aseptic compounding of sterile pharmaceutical products in biosafety cabinets (BSCs) and cleanroom environments (ISO 5/7/8).
Operate, monitor, and maintain fill-finish, compounding, and ancillary manufacturing equipment.
Oversee autoclaving, material preparation, labeling, and inventory management for sterile operations.
Maintain gowning qualifications and enforce proper aseptic technique among staff.
Lead and train team members in cleanroom procedures, equipment operation, and compliance with cGMP and GDP.
Review batch records, in-process documentation, and equipment logs for accuracy and completeness.
Support deviation investigations, CAPA implementation, and root cause analysis.
Ensure adherence to safety procedures, quality standards, and company SOPs.
Coordinate with Quality Assurance, Maintenance, and Supply Chain to support continuous operations.
Participate in lean manufacturing, 6S, and continuous improvement initiatives to enhance productivity and compliance.
Operate fill-finish and ancillary manufacturing equipment.
Perform autoclaving, compounding, labeling, inventory control, and LEAN tasks.
Maintain gowning qualifications and coach new hires on sterile operations.
Transfer finished products to inspection and labeling teams.
Targan – Raleigh, NC
Lead Electrical Mechanical Technician II 2023–2024
Assemble, install, test, and repair electrical and mechanical components, wiring, and systems for production equipment.
Interpret and work from engineering drawings, schematics, wiring diagrams, and technical manuals.
Perform preventive maintenance and troubleshoot equipment to identify root causes of malfunctions.
Collaborate with engineering and production teams to execute equipment builds, modifications, and upgrades.
Lead and mentor junior technicians, ensuring adherence to SOPs, safety procedures, and quality standards.
Conduct in-process quality checks to verify compliance with customer specifications and regulatory requirements.
Assist in developing and revising assembly procedures and documentation for production processes.
Maintain tools, test equipment, and work areas to meet 6S and Lean manufacturing principles.
Support continuous improvement initiatives to enhance efficiency, reduce downtime, and improve product quality.
Collaborated with technicians on assembly tasks and quality assessments.
KBI Biopharma – Durham, NC
Manufacturing Associate II, 2022–2023
Maintain gowning qualifications and enforce proper aseptic technique among staff.
Lead and train team members in cleanroom procedures, equipment operation, and compliance with cGMP and GDP.
Review batch records, in-process documentation, and equipment logs for accuracy and completeness.
Support deviation investigations, CAPA implementation, and root cause analysis.
Ensure adherence to safety procedures, quality standards, and company SOPs.
Coordinate with Quality Assurance, Maintenance, and Supply Chain to support continuous operations.
Participate in lean manufacturing, 6S, and continuous improvement initiatives to enhance productivity and compliance.
Operate fill-finish and ancillary manufacturing equipment.
Operated autoclaves and managed inventory/supplies for production teams.
Seqirus – Holly Springs, NC
Manufacturing Associate II 2022
Maintain gowning qualifications and enforce proper aseptic technique among staff.
Lead and train team members in cleanroom procedures, equipment operation, and compliance with cGMP and GDP.
Review batch records, in-process documentation, and equipment logs for accuracy and completeness.
Support deviation investigations, CAPA implementation, and root cause analysis.
Ensure adherence to safety procedures, quality standards, and company SOPs.
Coordinate with Quality Assurance, Maintenance, and Supply Chain to support continuous operations.
Participate in lean manufacturing, 6S, and continuous improvement initiatives to enhance productivity and compliance.
Operate fill-finish and ancillary manufacturing equipment.
Perform autoclaving, compounding, labeling, inventory control, and LEAN tasks.
Maintain gowning qualifications and coach new hires on sterile operations.
Transfer finished products to inspection and labeling teams
Guerbet LLC – Raleigh, NC
Setup Operator 2021–2022
Assembled and sanitized production equipment for batch operations.
Monitored equipment and documented performance per regulatory standards.
Supported Lean initiatives and autonomous maintenance activities.
Fresenius Kabi – Wilson, NC
Packaging Technician III 2020–2021
Operate and monitor automated and semi-automated packaging machinery, including inspection, labeling, and sealing systems.
Perform in-process quality inspections to ensure packaging meets company and regulatory specifications.
Troubleshoot and resolve equipment issues to minimize downtime and maintain production schedules.
Conduct preventive maintenance tasks and assist maintenance teams with repairs.
Complete batch records, logbooks, and electronic documentation accurately in compliance with cGMP/GDP.
Stage, verify, and reconcile packaging components and materials.
Assist with line clearance and changeover activities between production batches.
Adhere to all safety policies, SOPs, and cleanroom gowning requirements.
Collaborate with Quality Assurance and production teams to address deviations and implement corrective actions.
Participate in Lean manufacturing and continuous improvement initiatives to improve efficiency and reduce waste.
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Eaton Corporation – Morrisville, NC
Electrical Assembly Technician / Production Tech II 2011–2020
Read and interpret blueprints, wiring diagrams, and technical documentation to perform accurate installations.
Install and connect wiring, cables, and harnesses using proper crimping, soldering, and fastening techniques.
Perform quality checks, continuity tests, and functional testing of completed assemblies.
Identify and troubleshoot electrical issues, implementing corrective actions as needed.
Maintain tools, equipment, and workstations to meet 6S and Lean manufacturing standards.
Collaborate with engineers and production teams to improve assembly processes and product designs.
Document work performed, update assembly records, and ensure compliance with company SOPs and safety regulations.
Train and mentor junior assembly technicians on proper techniques and safety practices.
EDUCATION
Biomanufacturing Boot Camp Certification – Wake Tech / BioNetwork / NC State (2019)
Licensed Cosmetologist – Mitchell’s Hairstyling Academy, Raleigh, NC (1991)
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