Peter Barrera Email & Phone Number

Paris, France, Fr

• Responsible for all aspects of production, production readiness, staffing, quality, safety, delivery, and cost for Downstream department.• Ensure operations are conducted in compliance with regulatory agencies.• Complete final batch record reviews and logbook reviews.• Develop employees through training and one on one interactions.• Author, review, and approve of Quality Documents / revisions.• Maintain daily production scheduling to ensure overall production planning goals are met.• Participate in internal, external governing quality, and HSE audits.• Initiate and complete deviation investigations.• Lead process improvement and cost reduction change controls.

Paris, France, Fr

• Site administrator for the MASTER and PharmNet-Web environmental databases, performing database usage training for all departments, system audits (user / data), and SME during regulatory inspections.• Manage and develop ESUM, Data, & Support team.• Compile and analyze Environmental and LIMS Trending reports.• Author and review Quality Documents, Data Packs and Training Modules.• Support and maintain the integrity of EM databases - Data management service request process, sample points, templates in alignment with SWIs.

Paris, France, Fr

• Environmental Monitoring Operational Expert (SME) (Grade A, B, C, and D classified areas) Formulation, Filling, Inspection, Packaging Departments.• Manage EM processes within a team to meet the goals and priorities and ensure that EM operations are conducted in compliance with SOPs, SWIs and BFRs for Filling Department of Sanofi Pasteur.• Responsible for the EM of bacterial and/or viral products to meet established requirements and ensure that operations are conducted in compliance with cGMPs, CBER, WHO, EP and other regulatory bodies.• Plan, initiate and execute the overall EM sampling schedules (facilities and batch related), coordinating personnel activities with other EM and Manufacturing staff.• Generate work orders for EM equipment in the SAP system and interact with support functions like Sterility Assurance, IS, IT, and metrology.• Training and coaching of new employees in the areas of environmental monitoring, gowning, aseptic techniques, and daily release.• Investigator duties include initiation, assessment, and investigation of EM related deviations within Trackwise in a timely manner.• Data entry into Business Systems (MASTER, PharmNet-Web, SAP,etc)• ESUM Initiation and submission to Sterility Assurance (Data Management Service Request)• Support Departmental projects and improvement initiatives within the Level 1 +QDCI.

Paris, France, Fr

• Technician and qualified trainer within a team in fermentation, product recovery, and purification departments for processing of Meningococcal meningitis vaccine Menactra. • Technician and qualified trainer in media and buffer department. • Thorough working knowledge in cGMP’s• Participate in all aspects of production process. (Raw material weighing/dispensing, buffer/ reagent prep, media prep, CIP, SIP, StIP, Filter skid assembly/prep/disassembly, gram staining, spectrometer operation, YSI operation, decon autoclave operation, micro/ultra-filtrations, etc.)• Work to complete all assigned modules and training. • Follow all procedures (SWI/SOP’s) put into effect to ensure established requirements are met.• Knowledgeable in troubleshooting during process and preventative maintenance• Implementation of Shop Floor Database to all departments• Initiation, assessment, and investigation of Trackwise Deviations.• Generate work orders related to process in SAP system and interact with support functions like maintenance, metrology, and automation.• Responsible for completion of routine weekly and monthly environmental monitoring.

Paris, France, Fr

• Technician in fermentation department for processing of Meningococcal meningitis vaccine Menactra.• Technician in processing areas propagation and product recovery.• Exhibit exceptional cGMP and good documentation practices.• Knowledgeable user of SAP system performing commodity movement, issuing goods to cost center, and issuing goods to process order in order to maintain an accurate inventory throughout area. • Adhere to SOPs, SWIs, and Batch Production Records, in order to meet established requirements.• Experienced and fully trained in clarification area of influenza vaccine production

Paris, France, Fr

• Lead position in Health, Safety, and Environment department. • Hazardous Materials Management• Ensuring proper standard operating procedures requirements are met and proper handling of biohazard infectious medical waste.• Proper handling of various chemicals used for development of vaccines.• MSDS knowledge of various working chemicals in order to ensure safe storage, segregation, and transport.• Ensure recycling procedures are being followed in order to meet site recycling metrics.• Training of new personnel with operating various machinery including forklift.• Safety Training

• Built and maintained a profitable small business for over two years.• Responsible for all aspects of marketing, communication, inventory management, and sales.• Managed three part-time employees.• Maintained a high level of customer satisfaction and created a base clientele.