Tallis Mendonça Santos Email & Phone Number

Westport, County Mayo, Ireland

Project Engineer as contractor at Abbvie Westport where my main responsibilities are:• Safely coordinate the delivery of processing equipment to the site based on planned timelines and scope. • Coordination of equipment installation and services hook up, working with equipment vendors and engineering personnel.• Lead the Project Team or support the Project Manager in Factory Acceptance Testing program.• Coordination of all equipment documentation requirements.• Commissioning of equipment for validation activities.• Preparation of equipment training and maintenance protocols.• Report into the Project Manager on project progress and advice/support on key project outcomes• Contribute in a team environment on specific technical problem solving forums associated with product manufacture, aseptic fill and Packaging.• Deliver Process improvement projects.• Work with the relevant Business Unit team leaders to implement improvement opportunities• Lead regular Equipment/Facility Project review meetings.

Westport, County Mayo, Ireland

- Quality Control CQV/CSV Validation for new Laboratory;- Safely coordinate functional project teams for the delivery of laboratory equipment to the site based on planned timelines and scope. Laboratory equipment would include e.g., Bioassay lab equipment with OT systems, Bench-top equipment, Support equipment – BSCs, Fridges, Freezers, Incubators, etc. .- Working to the ASME BPE 2019 Standard and relevant ISPE Guidelines etc.- Coordination of laboratory equipment installation and services hook up, working with Equipment Vendors and Engineering personnel.- Participate in Factory Acceptance Testing program.- Coordination of all equipment documentation requirements.- Support commissioning and Qualification and Validation of Lab and support equipment.- Work with the E&T Senior Manager & System Owner / Project Team.- Provide input into all aspects of qualification and validation i.e., from installation through to the qualification and validation execution phases.- Utilize risk assessment and problem-solving tools in approach to validation strategy, investigations, and continuous improvement initiatives.- Develop, review and/or approve validation as required (e.g., specifications, plans, protocols, procedures, reports and associated data) for conformance to applicable regulations, client requirements, specifications, and procedures.- Collaborates with functional groups (project/ client) or contractors/vendors to resolve issues.- Initiate and implement change control activities in accordance with project/ client procedures.- Ability to work in a team, coordinate and enthuse colleagues.- Strong initiative and the ability to proactively identify required tasks.- An organized approach to working, task prioritization and time management.- Awareness & understanding of applicable regulations.

Montes Claros, Minas Gerais, Brazil

• Planning and coordination of Projects activities.• Lead team meetings and workshops.• Oversee the procurement of equipment, materials, and services, ensuring compliance with project specifications.• Plan resources and training in the project.• Hire Compliance and Validation Analysts and Lab Technicians.• Define QC layout and equipment number per process for new laboratory.• Ensure the correct qualification of equipment following established standards.• Ensure the implementation and compliance with the goals and procedures of the area under supervision.• Coordinate the implementation of the training plan in your area, ensuring compliance.• Communicate updates to both senior management and senior leadership as required.• Ensure the reliability and availability of data from the area under supervision.• Approve records and documents related to the area's processes in accordance with the standards defined by the company, ensuring compliance and data integrity;• Guarantee and incorporate all deliverables into project scheduling tools and delivery outputs.• Ensure the correct approval of production operational process procedures and support areas.• Challenge projects in your area, oriented towards the cLEAN® culture and a benchmark for best practices in the area.• Negotiate interdepartmental demands that influence the performance of the area under supervision, implementing actions that comply with established agreements.• Monitor the performance of technicians and analysts, providing technical and behavioral feedback.• Coordinate the use of material, financial and personnel resources, assessing the area's needs and contributing to the establishment of the area's budget.• Conduct meetings with the team, monitoring performance indicators and directing actions to correct deviations, as well as confirming processes against quality procedures, developing workers in these processes.

Montes Claros, Minas Gerais, Brazil

• Ensure the implementation and compliance with the goals and procedures of the area under supervision.• Coordinate the implementation of the training plan in your area, ensuring compliance.• Coordinate the workflow in the area that he supervises, as well as coordinate the administration of the personnel of the subordinates.• Ensure the reliability and availability of data from the area under supervision.• Approve records and documents related to the area's processes in accordance with the standards defined by the company, ensuring compliance and data integrity• Approve quality procedures as responsible for the operational process.• Ensure the correct qualification of equipment following established standards.• Challenge projects in your area, oriented towards the cLEAN® culture and a benchmark for best practices in the area.• Negotiate interdepartmental demands that influence the performance of the area under supervision, implementing actions that comply with established agreements.• Communicate the actions of the area he supervises to the company.• Respond to internal and external audits in the area.• Prepare and deliver training on the topics of the processes under its responsibility.• Monitor the performance of technicians and analysts, providing technical and behavioral feedback .• Coordinate the use of material, financial and personnel resources, assessing the area's needs and contributing to the establishment of the area's budget.• Conduct meetings with the team, monitoring performance indicators and directing actions to correct deviations, as well as confirming processes against quality procedures, developing workers in these processes.• Ensure the correct approval of production operational process procedures and support areas.• Ensure the release and rejection of batches of intermediate materials, such as raw material, printed packaging material, primary packaging material, secondary packaging material and final product.

Montes Claros, Minas Gerais, Brazil

- Validation of computerized systems and laboratory equipment.- Lead and participation in many implementations of new computerized equipment for QC. - Data integrity and Audit trail of it systems such as (autoclaves, TOC, Isolator, NIR (Near Infra-red), Instron, gallery;- Lead Implementation of QC Sampling Area (classified area used to sample raw materials/API to be use in Aseptic Production): creation of SOPs related to environmental monitoring, cleaning and behavior, PQ validation responsible and test executor.- Preparing and validation of, HPLC, NIR (Near Infra-Red), Autoclaves, Particle Counter, Laboratory Utensil Washer, active air samplers and solid particle counters (used for environmental monitoring). All of this equipment are categorized as computerized equipment - GAMP;- Validation instructor;- SAP PM instructor; - Management of maintenance plans and equipment in SAP. - SME of QC Sampling Area (Classified Grade C Area) and equipment such as Isolator to Test for Sterility, Autoclaves, Bag Sealer, Laboratory Utensil Washer, NIR (Near Infra Red), TOC equipment, Microscopy, Instron, HPLCs, particle counters and LAF Benches.- Maintenance responsible for Laboratory Equipment.- Responsible for sampling of Raw material at Quality Control.- Review of QC raw data and trend results.- Prepare and review SOPs (methods and equipment).- Act as technical resource (SME) and train other analysts in areas of expertise.- Conduct and document laboratory investigations.- Maintain the laboratory in an inspection-ready state.- Change Control management.- Treatment of non-conformity using LEAN tools.- SME of methods related to inspection of raw materials/API. - Calibration plan and requirements for laboratory equipment.- SME of method related to physical/mechanical test in insulin pen device.- Support in inspection and release of batches of raw materials/API.- Experience in systems SAP PM, LIMS ETQ Reliance, Empower 3 FR5 and QualityDocs (Veeva).

Executive Mba, Business Administration And Management, General

Engineer'S Degree, Automation Engineer Technology/Technician