Luis Carrasquillo Ortiz

Upstream Manufacturing Operation (OCT 2023 - Present)

• Expertise in cell thaw and culture activities across bioreactors up to 20K.
• Adherence to SOPs, MPRs, protocols, policies, regulatory requirements, GMPs, and safety guidelines.
• Participation in unit operations as per standard operating procedures and manufacturing batch records.
• Training competency in production operations through collaboration with team members and subject matter experts.
• Setup, maintenance, and use of cGMP equipment as per standard procedures.
• Compliance with company quality systems, safety procedures, and policies.
• Participation in a culture of continuous improvement.
• Collaboration with cross-functional partners for quality assurance, control, supply chain, and facilities.
• Operation of analytical equipment and chemical solutions.
• Optimization of bioreactor performance and scale-up procedures.
• Development and refinement of operating equipment specifications.
• Interpretation and communication of instructions.
• Compliance with GMP guidelines and environmental health and safety policies.
• Review of batch records for accuracy and compliance.
• Support investigations and corrective actions for batch execution issues.

Leading the Support Services Cleaning Crew (NOV 2022 - OCT 2023)

• Coordinating and managing daily operations of the cleaning team.
• Serving as a contact between CCS and AGC Biologic's for staff issues.
• Ensuring team compliance with company policies, regulatory requirements, quality systems, safety procedures, and SOPs.
• Training new team members on proper cleaning techniques and equipment usage.
• Reviewing and correcting documentation and requesting new logbooks.
• Participating in and supporting SOP and forming revisions for improvement.
• Escalating issues to the supervisor for guidance and a path forward.
• Demonstrating a commitment to fostering a safe work culture.
• Coordinating with the training department's new contract hires' training and onboarding plan.
• Verifying the status of on-site material inventory and placing orders as necessary.
• Monitoring trash compactor level and contacting MFG, QA, or utilities when a work order request is required.
• Participating in and supporting the cleaning crew with area and room cleaning activities.
• Communicating the current status, safety concerns, issues, and necessary information for Tier 1 with the supervisor.
• Being the on-call contact for both shifts during weekends and off-hours.
• Assisting in regular inspections to ensure compliance with safety regulations.

• Executes and documents cGMPs, SOPs, EHS procedures, MBR, and SAP.
• Troubleshoots SAP issues and adjusts accordingly.
• Operates Vial Washer, Depyrogenation Tunnel, RABS in Aseptic Filling System and Sealing System, ALUS System, and Lyophilization Dryer.
• Dominates and executes production activities in multiple manufacturing functional areas.
• Assists maintenance technicians in maintaining equipment and tools.
• Performs "troubleshooting" of all manufacturing equipment.
• Supports in the introduction of new products through technical support.
• Performs "setups" and "changeovers" of equipment and processes.
• Participates in the manufacturing change process of the manufacturing group.
• Ensures safety procedures and provides guidance to operators.
• Identifies opportunities and implements changes to improve unit cost, yield, cycle time, and quality issues.
• Uses acquired skills to develop new working methods.
• Performs cleaning levels and housekeeping standards as per SOP.
• Identifies opportunities for improvement and promotes sensitivity and good communication.
• Works with supervisor to develop clear goals and key objectives.

Maintained a safe working environment by enforcing strict adherence to safety guidelines and protocols.

• Provided on-the-job training to newly hired workers and team members.

• Proficient at Associate Manufacturing, schedule operations, performs initial review of manufacturing procedures/batch records.
• Train Mfg Operators and Associate Manufacturing on process theory, assist with recruiting effort, and supervise staff.
• Draft and revise complex documents (e.g. MPs, SOPs, technical reports, validation documents, investigation reports, etc.). Audit critical records. Propose corrective action for Quality incidents (CAPA). Assist, & plan improvement implementation related to routine functions. Perform data analysis (e.g., SPC) of critical process parameters. Lead capacity for equipment/process changes. Perform system owner responsibilities (i.e., process, document).
• Interact with other departments to implement planned improvements. Identify and propose solutions to complex problems. Interact with Process Development and assist in qualification process (IQ, OQ, PQ).
• Organized work to meet demanding production goals.
• Participated in regular team meetings to discuss progress, address challenges, and align on strategies for achieving production goals.
• Recorded and tracked daily production data for management reporting.
• Monitored and adjusted machine settings for optimal production output.
• Demonstrated versatility adaptability taking different roles responsibilities assigned including machine operator, quality inspector, or material handler.

• Responsible for assembling and/or producing products according to detailed manufacturing processes. Accountable for adhering to and enforcing all quality and safety guidelines. Perform and reviews cleaning records, SOPs, and batch records.
• Collect samples (ASL) and performed physical test, visual inspection and certified that the results are within the parameters set by the SOP.
• Responsible for receiving and organizing materials for formulation solutions.
• Performs in process tablet attribute checks in coating and GMP awareness in processing as governed by batch record, cleaning record, and SOPs.
• Performs manufacturing processes of increased. complexity/responsibility/criticality, for example Processing/Coating include machine reassembly/disassembly for cleaning purposes and/or minor trouble shooting based on training and operator experience level. Responsible to manufacture materials with approved manufacturing procedures and processes.
• Reconciled experimental and production batches and calculate yield.
• Responsible for the maintenance of production reports and data as documentation practices.
• Performs appropriate SAP transactions and retrieves required materials per BOM to complete the manufacturing order. Serves as Subject Matter Expert (SME) for the applicable production area, process and/or manufacturing equipment. Must follow all applicable standard operating procedures (SOPs), cleaning records, and batch records. Processes raw materials according to the validated process.
• Worked in a team environment collaborating with business partners from operations, quality, engineering, and or planning to resolve equipment/process issues and assist with investigations by providing valuable insight. Monitors and responds to equipment and process issues that may lead to non-compliance.

• Responsible for follow and execute machine operation according to standard operating procedures (SOPs) and batch record instructions
• Performs periodically check/examine units from good and or reject areas to ensure proper equipment function.
• Performs physicals and functional test to ensure quality product.
• Fit and assembled different components units for verification performances or functions.
• Responsible for verified equipment measures, due calibration date and good performance.
• Verified and documented parameters machines as “SPEC” or sheet parameters.
• Check counts and verifies the entire “batch” production.
• Responsible for print identification lots labels in poms system.
• Cleaned and sanitized manufacturing equipments and work areas, according to the safety rules and SOP’s.
• Responsible for documented In-Process Checker Chart.
• Performed releases materials.