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I am a CQV Engineer specializing in GMP manufacturing facilities for pharma and biotech clients. I support design, risk assessment and verification of clean/black utilities, critical process equipment and controlled environments across early project phases, collaborating closely with Engineering, Quality, Automation and Construction to ensure systems are designed, verified and delivered in compliance with GMP, GAMP 5 and ASTM E2500. I bring a structured, risk-based approach to qualification and validation, strong documentation practices, and hands-on experience with URS development, risk assessments, Design Qualification, and handover to validation. I thrive in cross-functional teams and am committed to delivering reliable, compliant facilities that support safe and efficient manufacturing.…I am a CQV Engineer specializing in GMP manufacturing facilities for pharma and biotech clients. I support design, risk assessment and verification of clean/black utilities, critical process equipment and controlled environments across early project phases, collaborating closely with Engineering, Quality, Automation and Construction to ensure systems are designed, verified and delivered in compliance with GMP, GAMP 5 and ASTM E2500. I bring a structured, risk-based approach to qualification and validation, strong documentation practices, and hands-on experience with URS development, risk assessments, Design Qualification, and handover to validation. I thrive in cross-functional teams and am committed to delivering reliable, compliant facilities that support safe and efficient manufacturing.

Goda Kliciute

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I am a CQV Engineer specializing in GMP manufacturing facilities for pharma and biotech clients. I support design, risk assessment and verification of clean/black utilities, critical process equipment and controlled environments across early project phases, collaborating closely with Engineering, Quality, Automation and Construction to ensure systems are designed, verified and delivered in compliance with GMP, GAMP 5 and ASTM E2500. I bring a structured, risk-based approach to qualification and validation, strong documentation practices, and hands-on experience with URS development, risk assessments, Design Qualification, and handover to validation. I thrive in cross-functional teams and am committed to delivering reliable, compliant facilities that support safe and efficient manufacturing.…I am a CQV Engineer specializing in GMP manufacturing facilities for pharma and biotech clients. I support design, risk assessment and verification of clean/black utilities, critical process equipment and controlled environments across early project phases, collaborating closely with Engineering, Quality, Automation and Construction to ensure systems are designed, verified and delivered in compliance with GMP, GAMP 5 and ASTM E2500. I bring a structured, risk-based approach to qualification and validation, strong documentation practices, and hands-on experience with URS development, risk assessments, Design Qualification, and handover to validation. I thrive in cross-functional teams and am committed to delivering reliable, compliant facilities that support safe and efficient manufacturing.

Available to hire

I am a CQV Engineer specializing in GMP manufacturing facilities for pharma and biotech clients. I support design, risk assessment and verification of clean/black utilities, critical process equipment and controlled environments across early project phases, collaborating closely with Engineering, Quality, Automation and Construction to ensure systems are designed, verified and delivered in compliance with GMP, GAMP 5 and ASTM E2500.

I bring a structured, risk-based approach to qualification and validation, strong documentation practices, and hands-on experience with URS development, risk assessments, Design Qualification, and handover to validation. I thrive in cross-functional teams and am committed to delivering reliable, compliant facilities that support safe and efficient manufacturing.

Work Experience

CQV Project Engineer at Jacobs Engineering Denmark

March 1, 2025 - Present

Supported early Basis of Design (BOD) and validation strategy development for a major biopharmaceutical manufacturing expansion. Authored URS and system descriptions to support commissioning, start-up, and handover of process and utility systems. Performed early-phase GxP risk assessments to define commissioning scope, criticality, and execution strategy. Supported design reviews and technical clarification workshops with engineering, automation and commissioning stakeholders. Ensured alignment between GMP expectations, commissioning requirements and engineering design inputs to enable smooth IQ/OQ readiness.

CQV Project Engineer at Jacobs Engineering Denmark

September 1, 2023 - March 1, 2025

Supported multiple large-scale pharmaceutical capital projects with focus on commissioning execution, start-up readiness, and transition to validation. Developed and reviewed URS for upstream, downstream, production support, utility, and COTS systems to support commissioning and handover. Performed system impact assessments and GMP risk assessments to define commissioning scope and system criticality. Supported Design Qualifications (DQ) activities, ensuring systems were designed for safe commissioning and operation. Developed and updated Validation and Verification Plans (VPLs) supporting commissioning-to-validation handover for autoclaves, cart washers, CIP/SIP systems, clean utilities (WFI, Clean Steam, Process Air) and room conditions. Prepared and reviewed CARA/DRA documentation, addressing commissioning risks and operability. Reviewed P&IDs, layouts and vendor documentation to ensure systems were commissioning-ready and compliant. Supported supplier oversight and FAT preparation,

HVAC Engineer at Buro Happold Engineering

September 1, 2022 - September 1, 2023

Designed and coordinated HVAC systems for complex building projects. Performed energy and load calculations. Coordinated with architects, mechanical and electrical engineers to ensure reliable system commissioning and operation, while maintaining compliance with safety, environmental and performance standards.