Simona Avramescu
Process Engineer – Automation SME, CSV Support
Experience
Process Engineer – Automation SME, CSV Support
UCB
- Lead the automation topics in process scope
- Review and approve functional and technical specifications, IO lists, wiring diagrams and challenge technical solutions for automation in scope
- Perform design review and design verification
- Lead and participate in the FAT/SAT of automation system
- Support the qualification phases, integration with 3rd party system and OsiPI archive system, actively preform the tasks to an efficient hand-over, with the follow-up of the associated punchlist
- Organize quality checks on field before each technical milestone activity
CQV Lead Lab & Small Equipment, CSV Support
Lonza
- Coordination of internal groups, as well as external service providers and suppliers
- Responsibility for the presentation of qualification documents during audits and inspections using KNEAT
- System boundary development and approval
- Design, installation and operational qualification preparation, execution and approval (URS, TSpec, GMP-RA’s, DQ, IQ, OQ) includes release to OPS
- Commissioning preparation, execution and approval, includes vendor supervision on their testing scope and quality
- Provide support in execution of design qualification for other direct impact systems
- Liaise closely with the relevant vendors/providers/contractors, project automation representatives and construction-phase representatives to ensure integration of activities and schedules with respect to the relevant systems
- Report and aid in the resolution of project issues, including maintaining the non-conformance records
- Assist in assessing project risk and evaluating the effectiveness of mitigation strategies applied
- Review and approve the CSV lifecycle documents: system configuration, ATRA, ERES, IV, IQ, OQ, SOP, support on validation of CSV relevant equipment
Lead Automation Engineer, MES – OSI PI consultant and trainer
Omnient
- Liaise with the automation development team providing a site perspective to the ongoing development of the group automation standards
- Evaluate performance data to feed into automation activity to deliver improvements in efficiency and operability within production
- Design, develop, implement, maintain, and improve customer's suite of PI software tools and related systems to meet the analytic needs of the business
- Make decisions regarding implementation, configuration, and installation of PI systems at customers
- Responsible for administration of the OSI PI system including collecting, historicizing, finding, analyzing, delivering and visualizing data
- Responsible for PI configuration, testing, tuning, monitoring, maintenance, and upgrades in combination with IT resources
- Responsible for OSIsoft PI System tag creation, tag monitoring, and tag maintenance
- Responsible for performance optimization and monitoring system health for the OSIsoft PI System; install, configure and maintain PI interfaces, PI connectors and PI adaptors
- Build asset framework hierarchies templates, elements and setup notifications, event frames and analysis
- Build PI Vision displays
CQV, CSV Lead - Member of Core Project Team
Takeda
- Ensure strategy and execution is consistent and delivered to project milestones with full SME responsibility for CSV activities for all streams based on validation master plan
- Interaction with operation and QA team
- Preparation of GxP computerized system lifecycle documents including validation plans, requirements specifications, risk assessments, 21 CFR 11, Annex 11 and DI assessments, commissioning, qualification protocols (DQ, IQ, OQ), requirements traceability matrices and validation reports, review and approve execution
- Preparation of protocols, intermediary reports and summary reports
- Preparation of formal change controls, manage deviations from design reviews, IQ, and OQ execution
- Design, produce and execute test plans and test protocols, managing and reporting findings and non-conformances raised during all types of testing
- Ensure that computer systems and their associated documentation are fully compliant with site-specific policies, regulations, good manufacturing practices and industry regulations
- Plan, organize and prioritize own workload and assist other team members to achieve agreed objectives and ensure all relevant deadlines are met
- Implement and complete change controls, CAPAs, and deviations for automated GMP systems and equipment
- Supervise validation and qualification activities in accordance with approved SOPs, plan, policies
- Review and approve all vendor lifecycle documentation; CQV witness for vendor FAT, SIT, SAT and commissioning
- Release validation/qualification reports
- Review and create site discrepancies and deviations investigation and closure
CSV, CQV, Automation Specialist
Simtechsoft Consulting
- Development and delivery of CQV documents (commissioning, qualification, validation test protocols)
- Ensure the validation status of computerized systems is compliant with cGMPs
- Implement a risk-based approach to the validation of computerized systems in accordance with EU GMP Annex 11, 15 and GAMP 5, ensuring compliance with the company QMS
- Manage validation documentation, commissioning test scripts, validation protocols, summary reports and risk assessments
- Author and report validation documentation to meet regulatory and company requirements including validation plans, user requirement specifications, design specifications and SOPs
- Author, review and execute qualification documents (DQ, IQ, OQ, PQ)
- Ensure strategy and execution is consistent and delivered to project milestones with full SME responsibility for CSV activities based on validation master plan
- Preparation of GxP computerized system lifecycle documents including validation plans, requirements specifications, risk assessments, 21 CFR 11, Annex 11 and DI assessments, commissioning, qualification protocols (DQ, IQ, OQ), requirements traceability matrices and validation reports, review and approve execution
- Preparation of protocol reports and summary reports
- Preparation of formal change controls, manage deviations from design reviews, IQ, and OQ execution
- Design, produce and execute test plans and test protocols, managing and reporting findings and non-conformances raised during all types of testing
- Ensure that computer systems and their associated documentation are fully compliant with site-specific policies, regulations, good manufacturing practices and industry regulations
- Plan, organize and prioritize own workload and assist other team members to achieve agreed objectives and ensure all relevant deadlines are met
- Review and approve all vendor lifecycle documentation; CQV witness for vendor FAT, SAT and commissioning
- Implement and complete change controls, CAPAs, and deviations for automated GMP systems and equipment
CQV & Automation Engineer
AstraZeneca
- Support all GMP compliance-based services (commissioning, qualification, validation) related to the automation scope project including data integrity, SCADA iFIX, OSI PI Vision and various PLCs
- Prepare, coordinate execution, review, and approve in-depth qualification/validation protocols CP, IQ, IOQ, OQ and reports according to GMP
- Assist in deviation investigation and resolution of problems and issues encountered during field execution activities
- Ensure strategy and execution is consistent and delivered to project milestones with full SME responsibility for CSV activities based on validation master plan
- Preparation of GxP computerized system lifecycle documents including validation plans, requirements specifications, risk assessments, 21 CFR 11, Annex 11 and DI assessments, commissioning, qualification protocols (DQ, IQ, OQ), requirements traceability matrices and validation reports, review and approve execution
- Preparation of protocol reports and summary reports
- Preparation of formal change controls, manage deviations from design reviews, IQ, and OQ execution
- Design, produce and execute test plans and test protocols, managing and reporting findings and non-conformances raised during all types of testing
- Ensure that computer systems and their associated documentation are fully compliant with site-specific policies, regulations, good manufacturing practices and industry regulations
- Plan, organize and prioritize own workload and assist other team members to achieve agreed objectives and ensure all relevant deadlines are met
- Review and approve all vendor lifecycle documentation; CQV witness for vendor FAT, SAT and commissioning
- Execute commissioning, validation and qualification activities in accordance with approved SOPs, plan, policies
CSV, Automation Engineer
Consultant in pharmaceutical industry
- Produce documentation for 3rd party consultant company as user requirements, design specification, functional specification and traceability matrix
- Produce validation plans, IQ/OQ/PQ protocols, test scripts, and SOPs as required to meet 21 CFR Parts 210, 211, 11, EU Annex 11, GAMP 5
Automation Engineer
Thai Union
- Produce documentation as functional design, software design specification
- Software development (CFC, SFC, SCL), hardware configuration with Simatic PCS7 v8.2, instruments configuration with Simatic PDM v9.0, FAT, commissioning
CSV, Automation Engineer
GEA Pharma Systems
- Produce documentation as functional design specification, detail design specification, PLC and HMI software design specification for machineries in granulation process (PMA, fluid bed dryer, EPH, wash skids)
- Software development in Step7 and TIA WinCC, iFIX SCADA software, hardware configuration, software integration
- Produce and execute test protocols, bench test, commissioning, FAT
Automation Engineer
Siemens
- Produce functional design specification, software design specification, COMOS – CMT documentation
- PCS7 software development (CFC, SFC, SCL), hardware configuration
- Produce and execute test protocols, FAT
Automation Engineer
United Utilities Water
- Produce functional design specification, software design specification
- PCS7, Step7, Allen Bradley and WinCC software development, hardware configuration
- Produce and execute FAT, commissioning
Automation Engineer
Siemens
- Produce functional design specification, software design specification
- PCS7 software development (CFC, SFC, SCL), Simatic Batch, hardware configuration
- Produce and execute FAT
Lead Automation Engineer
Siemens AG
Prepare conceptual design packages and engineering budgetary cost estimation
Define, approve and review the technical solutions for oil and gas automation projects
Support the project regarding software engineering, development, implementation/integration, consultancy and training
Technical lead role on SCADA, RTUs, ESD, DCS PCS7 and PLC system project design and provide support during implementations
Technical Project Manager and supervisor for pilot test project: mass balance and leak detection system at PetrolOffisi-OMV Istanbul, Turkey (May 2013 – June 2013)
Head of Automation Department
Siemens SRL
- Lead a team of engineers to ensure complete engineering on time, develop priorities for application engineering, review design of automation solutions
- Build up a support and execution team within the division as well as outside of the division, support sales staff technically in estimation and offer making and technical presentations
- Set up the strategy with focus on creating business opportunities
Sales Manager
Siemens SRL
Develop new customer accounts and partnerships to grow business volume with existing customers
Responsible for achieving order, sales and margin targets as well as managing budget commitments
Identify the potential of projects and develop them proactively together with the customer
Qualify potential projects and participate in the Bid/No-Bid decision
Participate in the process selection and design and the proposal development, preparation of process concepts and project specifications
Achievements:
Fire detection system in electrical substation at OMV-Petrom Petrobrazi refinery (€1.2M)
Burner management system and flare system at OMV-Petrom Petrobrazi refinery (€1.2M)
Head of Automation Department & Project Manager
Siemens SRL
Industrial automation and control systems consulting, project management and leading, technical support, automation software design and development
Implement creative solutions and architecture, problem resolution and management for new and existing systems
Develop (PCS7, Step 7, WinCC), review, approve for new projects, process improvements, operation and maintenance of automation systems: PLCs, DCS, ESD, SCADA; integration into IS/IT architecture and process network management
Project manager for all automation projects, implementation projects for maintenance business, pre-sales, sales activities for oil and gas companies in Romania
Achievements:
Local measurements connections with real time process database using Aspen InfoPlus.21 and OSIsoft PI Vision; fiber optic cable routing for local measurements connections (€1.5M)
Fire detection system in electrical substation in refinery (€1.2M)
Sales manager for EPC project: burner management system and flare system at Petrom Petrobrazi refinery (€1.2M)
Expert automation engineer at Charter Tech, UK for FAT of burner management and flare system
Automation Control Engineer
Siemens SRL
Provide process solutions, system integration, turnkey installation, build-own-operate solutions, operation and maintenance service, FAT, SAT for process
Support and lead the development and execution of automation work, design complex systems integrating hardware and software for oil and gas and industry processes
System implementation, develop SCADA application, software design and programming in Simatic Step 7, PCS7, WinCC, WinCC flexible, Protool, commissioning, start-up, operations; monitoring, adjusting and controlling process equipment, maintenance routines
Achievements:
Software application for cement industry at Holcim Cimpulung Muscel Romania (PCS7 CEMAT library)
Waste water treatment plant automation system for Cernavoda Romania
Various PLC and user interface programming for industry projects including OMV gas station storage, Air Liquide Calarasi, Petrom-OMV tank automation
Automation Control Engineer
SC IPROLAM SA
Design and implement automation solutions for rolling mill and automotive industry
Responsible for pre-commissioning, commissioning and start-up procedures, develop software applications for industrial plants, configure networking communication for DCS and SCADA (Step7, WinCC)
Achievements:
Commissioning and start-up of pressure test stand for flexible tubes in automotive industry
Commissioning, start-up, test run for high pressure test machine for pipes (1300 bars) at SILCOTUB Tenaris Zalau
Computers Engineer
Continental Automotive Products
- Software development for machineries in automotive industry
Software & Hardware Technician
S.C. FLAMINGO COMPUTERS S.A.
- Service and troubleshooting PCs, hardware and software installation
Summary
- Result-oriented, enthusiastic and dedicated technical specialist with more than 19 years’ experience in Pharmaceutical, Bioscience, Oil&Gas, Industry, Waste Energy;
- Results-driven and methodical in achieving objectives, active and dynamic approach to work;
- Strategic thinking and determined;
- Certified Project Manager.
Skills
- Driving License: B Category
Languages
Education
Oil and Gas University
Diplomat Engineer · Automation and Industrial Information - Engineering, Computers Systems and Process Science · Ploiești, Romania
Certifications & licenses
Certified Project Manager
PM@Siemens For Small Projects
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