Mireya Jaime

Buffer Preparation Area/ Component Prep Area

• Experience in Buffer Preparation for Large and Small Buffers.
• Experience with CIP, PT, SIP, PTXOL, SIPXOL, and POST-SIP PT.
• Experience using PCS, WERUM, eBR, LIMS, RT Reports, Level 2 systems, PI Batch, PI Vision, SAP, SYMPHONY, Smartsheet and SCADA.
• Performance of filter integrity testing (pre- and post-use) using Sartocheck.
• Operation of sampling equipment including conductivity, in-line/off-line pH, and Osmolality.
• Experience in routine manufacturing processes supporting validation activities.
• Basic troubleshooting support for Buffer Prep and Component Prep systems.
• Compliance with SOPs, GMP, and GLP requirements.
• Forklift license.
• Certified trainer in Buffer Prep and Component Prep areas.
• Execution of process validations and sampling runs.
• Experience handling eBR Level 2.

Trainer / Subject Matter Expertise

• Trainer (Train-the-Trainer) performance in AML6, CIP (SME), Small and Large Buffer preparation, Novaseptum devices, Point of Use Water systems, weight scales, sample collectors, sanitary connections, autoclaves, washers, tank operations, pH and conductivity measurements, filter assembly, and pipette use.

Leadership & Operations

• Acting Lead with coaching for Buffer Prep and Component Prep areas within the Downstream organization.
• Participation in tactical and strategic planning for downstream manufacturing processes.
• Team Leader during clinical and commercial manufacturing campaigns.

Continuous Improvement & Quality

• Experience using Continuous Improvement tools such as 5 Whys, OPL, 6 Box, RYH, See Card, 6'S, BIN items and EHS Report (KYT).
• Experience in root cause analysis and triage discussions.
• Support to Maintenance for RTS activities and system troubleshooting.
• Batch record review, oversight, and internal audit support.
• Communication and reporting using Smartsheet during shift changes, Symphonic, WCT, schedule meetings and staff communications.

Safety & Compliance

• Safety Champion.
• Member of the Evacuation Team.

• Process operation of Packaging Equipments from Combination Product Sureclick Devices Business Unit (Lines 4137 / 319), according to SOP’s and GMP practices.
• Actively participate in cleaning, clearance and Setup of manufacturing areas following procedures and Standard Works.
• Perform review and approval of Packaging batch records using EBR system to deliver batch documentation for disposition on the specified timeframe.
• Perform visual inspections and In Process Checks of product along the process to ensure quality attributes .
• Monitor and follow up operations to identify equipment malfunctioning, waste, quality defects and safety risks.
• Seek opportunities to to meet and improve execution times of tasks such as Changeovers and Batch record reviews.
• Certified on equipment and processes such as Sortimat Assembly Machine, Weiler and IMA Labelers, Schubert Cartoner, Serialization Process, Advisor Systems, SATM Device testing equipment, Product Reconciliation among others. Calculate time exposures of products to light and room temperature.