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Carolina Moreno

@carolinamoreno1

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I lead pharmaceutical CQV and aseptic validation across complex GMP manufacturing processes.

Netherlands

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What I'm looking for

I'm looking to lead or contribute to GMP validation, CQV, and aseptic manufacturing work where I can improve processes, solve complex problems, strengthen quality systems, and collaborate with multidisciplinary teams.

At Prothya Biosolutions, I lead the CQV team and coordinate validation activities around company priorities, execution, and efficient organization.

I work across the manufacturing process lifecycle, including process design, qualification, continued process verification, risk assessments, holding-time validation, and cleaning validation.

My work in aseptic manufacturing includes aseptic process simulation, sterilizing filtration, moist-heat sterilization, and depyrogenation validation. I also bring experience qualifying critical systems and equipment, including autoclaves, ovens, depyrogenation tunnels, WFI, pure steam, and medical gases.

Previously, I led validation teams at Abbott and Laboratorio Pablo Cassará and delivered consulting projects through ISOPHAR Latam. As a pharmacist with more than 10 years in industry, I enjoy cross-functional teamwork, problem solving, process improvement, and strengthening GMP quality systems.

Experience

Work history, roles, and key accomplishments

Current

Senior Engineer Specialist

Current

Prothya Biosolutions

Sep 2022 - Present (4 years)

Leading CQV team and coordinating activities in alignment with company priorities while ensuring efficient organization and execution.

Subject Matter Expert for:

•Manufacturing Process lifecycle: Stage 1 Process Design - Stage 2 Process Qualification - Stage 3 Continued Process Verification - Manufacturing Process Risk Assessment (Define CQA and CPP) - Holding Time Validation

•Sterilization an

Head of Validation

Laboratorio Pablo Cassará

Nov 2021 - Jun 2022 (7 months)

Team structure: six analysts (junior/ senior) in charge, direct report to the Quality Management

Responsibilities:
Developing and maintaining the Validation Master Plan updated; ensure the validated status of processes, critical systems, aseptic procedures.

Coordination of process validation tasks, definition of validation strategies; updating of the documentation associated with the new guideli

Consulting and project leadership

ISOPHAR Latam

Mar 2021 - Nov 2021 (8 months)

Responsibilities:
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External support in Compliance and Validation tasks;

Maintenance and continuous improvement of the quality system, responsible for its management.;

Project leader in a medical device company (manual aseptic process of bovine pericardium patches); process improvement and standardization;

Project leader in a medicinal specialty company (blood bags containing pharmaceutically

Team leader Validation

Abbott

May 2017 - Aug 2020 (3 years 3 months)

Team structure: six analysts (junior/ senior) in charge, direct report to the Validation’s Management

Responsibilities:
Drafting of engineering documentation such as URS. Installation, configuration and commissioning of equipment, commissioning of FAT/SAT and IOQ and PQ and activities (validation of equipment, processes and cleaning);

Developing and maintaining the Validation Master Plan updated

Senior Validation Specialist

Laboratorio Internacional Argentino S.A.

Apr 2011 - May 2017 (6 years 1 month)

Responsibilities:

Monitoring of the tasks established in the validation master plan.

Classification of areas with LASAIR III particle counter equipment according to ISO 14644; classification of classes ISO 5, ISO 7 and ISO 8. Drafting of the documentation package for its approval by management.

Qualification of thermal equipment performance (autoclave, ovens and depyrogenation tunnels) in conj