Pedro Barillas

• Interim Calibration Manager. Fill in for manager role during manager vacation and when role was vacant. Manager level task fell on to me, including meeting, scheduling, running all aspects of the metrology team.
• Maintained an ISO 17025 compliant calibration systems
• I participated in the review, update and improve of SOPs, and calibration protocols.
• Review calibration certificates.
• Root cause analysis
• Experience in measurement traceability and measurement uncertainty
• I was the point of contact for external service providers. Scheduling and escorted. I also worked with accounting to pay and modify Purchase Orders.
• Maintained a safe work environment through strict adherence to safety protocols during metrology operations.
• Supports audits and inspections by providing documentation and explaining our calibration process.
• Actively collaborated with QA, QC, Validation, Production and Maintenance teams to ensure instruments are ready to use and minimize down time.
• Job site decommissioning, decommissioning equipment and ensuring all documentation is accounted for Document Control Department
• Proficient at Blue Mountain Regulatory Asset Manager. Asset induction, asset scheduling and assigning work. Audit Trails. Work plan templates. Processing work request into proper work orders and assigning it to the proper personnel.
• Developed comprehensive training materials for new hires, fostering a culture of expertise in metrology principles and practices.

International Process Solutions is an ISO 17025 accredited Company. I worked at many client’s sites in pharmaceutical/medical industry as a field metrology tech until I became lead metrology tech at a client site, Audentes Therapeutics (later became Astellas Gene Therapies) for greater part of 3 years. Work multiple GMP/cGMP clean room environments, and followed clients SOP along with IPS's SOP. GMP gowning requirements from light to heavy gowning.

• Performance monthly to annual calibration. On demand calibrations. Into service calibration for new equipment and Exit calibration for decommissioning equipment. Closed out work orders.
• Thermal Calibration of Refrigerators, Freezer, ovens, incubators and thermal chambers.
• CO2 calibration of incubator
• Oxygen sensor calibration
• 4-20mA calibration on transmitters
• Install transmitters remove replace transmitters
• pH meter calibration
• Pressure transmitters and gauges. PSI, differential pressure, inches of water,
• Wiring harness, crimping, cabling, cutting
• Followed Lock out/ tag out procedures
• HMI, EMS, systems, data monitoring and data collection systems
• Software used, Metteam, Blue Mountain, MasterControl, MS office suite, Veeva
• Demonstrated expertise in the use of various tools and software applications for precise data collection during calibration processes.
• Continuously expanded knowledge base through ongoing professional development opportunities such as training courses or certifications.

I worked as part of the Research and Development Team (R&D), developing new medical device products, testing new concepts and improving current products to meet client’s needs. Started work during AlterG’s initial startup years and well into its maturity. My 8+ years led me to a vast variety of task across all departments. My main duties revolved around prototyping and testing.

• Built Mechanical prototypes/mockups per Engineers request. Used a variety of materials, machine shop tools and Hand tools safely
• Assembled and troubleshoot electronic boards. Reword damage PCB.
• Cable/wire harness assembly and engineering. Connector sourcing. Cable routing, connector crimping and labeling. Create cable documentation and wire diagrams. Worked with cable vendors to bring harness into mass production.
• Write, proofread and develop test procedures. Creating test setup Compiling test reports.
• Accelerated life testing and Continuous Data Capture
• Assist in product design. Gave engineers design feedback and suggestions for improvement.
• Experience in the process to bringing a prototype into manufacturing of a medical company to meet UL, IEC 60601-1-1 and IEC 60601-1-2 certification while following a ISO-13485 medical device- quality management system and keep up to date with the lattes SOP standards
• Verification and Validation of software, sub-assemblies and entire product.
• Purchased R&D materials, hardware and tools. Handle Purchase Orders and dealt with vendors daily.
• Filled in to help Field Service department. I dealt with customer issues in person and over the phone. I traveled to customer sites locally and across the USA to Performed full system repairs and installations under no supervision. Handled shipping Logistics. Train service technicians.
• Assisted in set up of AlterG Inc. manufacturing operations. Created sub-systems assembly procedures. Implementation of Lean manufacturing. Organized Trained assembly technicians.
• Help Marketing department. Trade show equipment set up and service product for presentation. Built and Maintain Mobil Showroom trucks.