BRIAN RUDY

• Train associates on SOPs, safety training, and government regulations
• Live Right the First Time Execution
• Plan and manage daily operations to improve efficiency
• Review batch records and log books
• Ensure equipment is calibrated and ready for use
• Participate in deviation investigation
• Perform CIP/SIP on UF/DF and Chromatography to purify protein
• Teach the team how to troubleshoot issues to minimize downtime and maintain product quality
• Designed new SUT material that reduced risk and cost by $30,000 annually.

• Actively provided training to technicians during commissioning
• Employed critical thinking in breaking down problems, evaluating them for solutions, and determining the best path forward
• Lead the mechanical training to achieve steady improvements
• Responsible for conducting downstream processing including Chromatography, UF/DF, utilizing aseptic techniques and behaviors
• Investigate and determine the cause, and develop a corrective action to ensure future prevention.

Project manager for the construction and renovation of home remodeling and maintenance.

Plan manpower and equipment according to schedule.

Read blueprints for framing layout, supervised and performed construction operations.

Collaborate efforts with engineering, plumbers, and electricians.

Perform safety inspections and scheduled permit inspections and ensure quality compliance.

Emphasize a culture of exceeding expectations, safety, and accountability.

• Held Tier meetings and gave room assignments
• Lead, coach, and mentor team to execute production plans
• Coordinated technicians to arrange manufacturing suites before new building commissioning
• Reviewed all log books and batch records
• Investigated deviations, and performed CAPA
• Held training on findings
• Coordinated with validation engineers to qualify equipment.

• Completed an extensive program to become a certified trainer
• Trained technicians for building engineering runs, PPQ and qualification.

• Performed formulation activities, COP, and SOP
• Operate fill/finish automated filling machinery, and make adjustments to achieve maximum efficiency
• Performed bulk thawing, pooling, filling, lyophilization, and capping, activities.

Reduced equipment downtime by performing timely

maintenance and troubleshooting technical issues.

Increased overall productivity with effective time management strategies and efficient work procedures.

Moved railcars utilizing trackmobile.

Assist with the coupling and uncoupling of cars, operate switches,

Lead safety meetings and trainings.

Inspect equipment on cars for repairs.

Heavy equipment operator of front end loader and backhoe.