Cqv / Validation / Process Engineering - Aerospace & Life Sciences

Capgemini; Castelo Branco; Hybrid; EUR 45,000 - 65,000; Full time

Benefits offered by this job

Hybrid work model

Health and life insurance

Referral program with bonuses

Great office locations

Job summary

Capgemini Engineering is seeking professionals with experience in CQV, Validation and/or Process Engineering to join projects in the Aerospace & Life Sciences industries.

Responsibilities include supporting commissioning, qualification, validation and process engineering activities, preparing and maintaining technical documentation, and contributing to CAPA and risk assessment activities.

Qualifications

• 3+ years of professional experience in validation, CQV or process engineering.
• Experience in regulated environments within Aerospace and/or Life Sciences.
• Knowledge of validation methods, documentation and quality systems.
• Experience with IQ/OQ/PQ, risk assessment, CAPA, deviations and change control.

Responsibilities

• Support commissioning, qualification, validation and process engineering activities.
• Prepare, review, execute and maintain validation documentation.
• Create qualification and validation protocols, test cases, reports and evidence.
• Support industrialization, process validation and process optimization.
• Participate in FAT/SAT activities and remote support when required.
• Assist in deviation management, root cause analysis and corrective actions.
• Contribute to CAPA, change control and risk assessment activities.

Skills

CQV

Validation

Process Engineering

Aerospace

Life Sciences

IQ/OQ/PQ

CAPA

Risk Assessment

English

Education

Engineering degree

Technical/Scientific background

Tools

Kneat

Quality management systems

Job description

CQV / Validation / Process Engineering - Aerospace & Life Sciences

• At Capgemini Engineering, we are looking for professionals with experience in CQV, Validation and/or Process Engineering to join our projects within the Aerospace & Life Sciences industries
• Depending on your experience and project, your responsibilities may include:
• Support commissioning, qualification, validation and/or process engineering activities within regulated and quality-driven environments.
• Prepare, review, execute and maintain technical, validation and qualification documentation, ensuring compliance with applicable procedures, SOPs, quality standards and project requirements.
• Prepare and execute qualification and validation protocols, test cases, reports and supporting evidence, including IQ/OQ/PQ activities where applicable.
• Support industrialization, process validation, process optimization and manufacturing engineering activities.
• Participate in FAT and SAT activities, including remote support when required.
• Support deviation and test incident management, investigation, root cause analysis and definition of follow-up actions.
• Contribute to CAPA, change control and risk assessment activities, according to project and industry requirements.
• Support the development, standardization and continuous improvement of manufacturing and engineering processes.
• Work with electronic validation, qualification, documentation or quality management systems, such as Kneat or equivalent tools, depending on the project.
• Collaborate closely with multidisciplinary and international teams, ensuring effective communication between Engineering, Manufacturing, Quality and other project stakeholders.
• Participate in regular project follow-up meetings, report progress and ensure that documentation and project trackers remain up to date.

YOUR PROFILE

• Academic background in Engineering, Biotechnology, Bioengineering, Biomedical Engineering, Biomedical Sciences, Pharmacy or another relevant technical/scientific field.
• 3+ years of professional experience in one or more of the following areas:
• Validation / Process Validation;
• Process Engineering;
• Manufacturing Engineering;
• Quality Engineering.
• Professional experience within Aerospace/Aeronautics and/or Life Sciences, including Pharmaceutical, Biotechnology or Medical Devices environments.
• Experience with validation, qualification, testing, commissioning or industrial process activities, according to the relevant industry.
• Knowledge of methodologies such as IQ/OQ/PQ, risk assessment, root cause analysis, CAPA, change control, deviations, PFMEA or continuous improvement is valued.
• Experience preparing and maintaining technical documentation, protocols, reports, procedures, test evidence and/or engineering documentation.
• Experience with electronic validation, documentation or quality management systems is considered an advantage.
• Strong analytical and problem-solving skills, with attention to detail and quality.
• Ability to work effectively in multidisciplinary and international teams.
• Good communication skills and a good level of English.
• Curiosity, adaptability and motivation to continuously develop technical knowledge.

WHAT YOU’LL LOVE ABOUT WORKING HERE

Join a multicultural and inclusive team environment;
Enjoy a supportive atmosphere promoting work-life balance;
Hybrid work model;
Your career growth is central to our mission. Our array of career growth programs and diverse professionals are crafted to support you in exploring a world of opportunities;
Access valuable training and certifications in cutting-edge technologies;
Engage in exciting and innovative projects;
Health and life insurance;
Referral program with bonuses for talent recommendations;
Great office locations.

ABOUT CAPGEMINI

Capgemini is the business transformation partner for enterprises in the age of AI. We help organizations imagine and build an intelligent, sustainable future, combining AI, technology and human ingenuity to transform how they operate, innovate and grow. With unique end-to-end capabilities spanning strategy, technology, engineering and intelligent operations, we bring together deep industry expertise and market-leading capabilities in AI, cloud and data to turn ambition into measurable business outcomes at scale. Supported by a robust ecosystem of partners and nearly 60 years of expertise, Capgemini is a responsible and diverse global organization of over 410,000 team members in more than 50 countries.