Simona Avramescu - Process Engineer – Automation SME, CSV Support

Q: What languages does Simona speak?

Simona speaks the following languages: Romanian (Native), English (Advanced), German (Intermediate), Spanish (Intermediate) .

Q: How many years of experience does Simona have?

Simona has at least 23 years of experience. During this time, Simona has worked in at least 15 different roles and for 16 different companies . The average length of individual experience is 1 year and 2 months . Note that Simona may not have shared all experience and actually has more experience.

Q: What is Simona's latest experience?

Simona's most recent position is Process Engineer – Automation SME, CSV Support at UCB .

Q: What companies has Simona worked for in recent years?

In recent years, Simona has worked for UCB , Lonza , Omnient , and Takeda .

Q: Which industries is Simona most experienced in?

Simona is most experienced in industries like Energy , Manufacturing , and Pharmaceutical . Simona also has some experience in Utilities , Biotechnology , and Automotive .

Q: Which business areas is Simona most experienced in?

Simona is most experienced in business areas like Quality Assurance , Product Development , and Operations . Simona also has some experience in Project Management , Production , and Information Technology .

Q: Which industries has Simona worked in recently?

Simona has recently worked in industries like Pharmaceutical , Biotechnology , and Manufacturing .

Q: Which business areas has Simona worked in recently?

Simona has recently worked in business areas like Quality Assurance , Operations , and Project Management .

Q: What is Simona's education?

Simona holds a Bachelor in Automation and Industrial Information - Engineering, Computers Systems and Process Science from Oil and Gas University .

Recommended expert

Romania

Check rate

Experience

Aug 2024 - Present

1 year 9 months

Belgium

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

Jul 2022 - Jul 2024

2 years 1 month

Switzerland

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

Jan 2022 - Jun 2022

6 months

Romania

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

May 2020 - Dec 2021

1 year 8 months

Germany

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

Jan 2020 - Apr 2020

4 months

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

May 2019 - Dec 2019

8 months

Sweden

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

Sep 2018 - Apr 2019

8 months

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

Jan 2018 - Aug 2018

8 months

Germany

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

Nov 2016 - Oct 2017

1 year

United Kingdom

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

Jun 2015 - Sep 2016

1 year 4 months

United Kingdom

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

Mar 2015 - May 2015

3 months

United Kingdom

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

Jan 2014 - Feb 2015

1 year 2 months

United Kingdom

Automation Engineer

Siemens

Produce functional design specification, software design specification
PCS7 software development (CFC, SFC, SCL), Simatic Batch, hardware configuration
Produce and execute FAT

Aug 2012 - Dec 2013

1 year 5 months

Germany

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)

Jan 2012 - Jul 2012

7 months

Romania

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

Nov 2010 - Dec 2011

1 year 2 months

Romania

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)

Mar 2009 - Oct 2010

1 year 8 months

Romania

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

Sep 2005 - Feb 2009

3 years 6 months

Romania

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

Jul 2004 - Aug 2005

1 year 2 months

Romania

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

Dec 2003 - Jun 2004

7 months

Germany

Computers Engineer

Continental Automotive Products

Software development for machineries in automotive industry

Jan 2003 - Nov 2003

11 months

Romania

Software & Hardware Technician

S.C. FLAMINGO COMPUTERS S.A.

Service and troubleshooting PCs, hardware and software installation

Industry Experience

See where this freelancer has spent most of their professional time.

Experienced in Energy, Manufacturing, Pharmaceutical, Utilities, Biotechnology, and Automotive.

Energy

Manufacturing

Pharmaceutical

Utilities

Biotechnology

Automotive

Business Area Experience

See which departments and functions this freelancer has contributed to most.

Experienced in Quality Assurance, Product Development, Operations, Project Management, Production, and Information Technology.

Quality Assurance

Product Development

Operations

Project Management

Production

Information Technology

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

Romanian

Native

English

Advanced

German

Intermediate

Spanish

Intermediate

Education

Oct 1998 - Jun 2003

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

Statistics

Experience

Total positions 20

Experience in Energy 9 y

Avg length 1 y 1 m

Longest experience 3 y 5 m

Global Experience

Countries worked in 6 (Romania, Germany, United Kingdom, Belgium, Switzerland, +1)

Primary country Romania

Expertise

Recent roles Process Engineer – Automation SME, CSV Support, CQV Lead Lab & Small Equipment, CSV Support, Lead Automation Engineer, MES – OSI PI consultant and trainer

Main industries Energy, Manufacturing, Pharmaceutical

Main business areas Quality Assurance, Product Development, Operations

Qualifications

Highest degree Bachelor

Certifications earned 2

Profile

Created

January 2026

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Frequently asked questions

Do you have questions? Here you can find further information.

What languages does Simona speak?

Simona speaks the following languages: Romanian (Native), English (Advanced), German (Intermediate), Spanish (Intermediate).

How many years of experience does Simona have?

Simona has at least 23 years of experience. During this time, Simona has worked in at least 15 different roles and for 16 different companies. The average length of individual experience is 1 year and 2 months. Note that Simona may not have shared all experience and actually has more experience.

What roles would Simona be best suited for?

Based on recent experience, Simona would be well-suited for roles such as: Process Engineer – Automation SME, CSV Support, CQV Lead Lab & Small Equipment, CSV Support, Lead Automation Engineer, MES – OSI PI consultant and trainer.

What is Simona's latest experience?

Simona's most recent position is Process Engineer – Automation SME, CSV Support at UCB.

What companies has Simona worked for in recent years?

In recent years, Simona has worked for UCB, Lonza, Omnient, and Takeda.

Which industries is Simona most experienced in?

Simona is most experienced in industries like Energy, Manufacturing, and Pharmaceutical. Simona also has some experience in Utilities, Biotechnology, and Automotive.

Which business areas is Simona most experienced in?

Simona is most experienced in business areas like Quality Assurance, Product Development, and Operations. Simona also has some experience in Project Management, Production, and Information Technology.

Which industries has Simona worked in recently?

Simona has recently worked in industries like Pharmaceutical, Biotechnology, and Manufacturing.

Which business areas has Simona worked in recently?

Simona has recently worked in business areas like Quality Assurance, Operations, and Project Management.

What is Simona's education?

Simona holds a Bachelor in Automation and Industrial Information - Engineering, Computers Systems and Process Science from Oil and Gas University.

Does Simona have any certificates?

Simona has 2 certificates. These include: Certified Project Manager and PM@Siemens For Small Projects.

What is the availability of Simona?

Simona is immediately available full-time for suitable projects.

What is the rate of Simona?

Simona's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.