Validation Engineer

Rhian_Convatec; Reynosa; Presencial; USD 30,000 - 70,000; Jornada completa

Descripción de la vacante

An established industry player in medical solutions is seeking a detail-oriented Validation Engineer to ensure compliance with quality standards and regulations. This role involves maintaining validation procedures, training staff, and collaborating with various departments to ensure effective resource planning for revalidation activities. Join a global team dedicated to improving patient outcomes and making a positive impact on lives. If you are passionate about quality assurance and have a background in engineering, this is an exciting opportunity to contribute to innovative medical technologies.

Formación

• Bachelor's degree in Industrial or Process Engineering required.
• 2 years of experience in validation processes and calibrations.

Responsabilidades

• Maintain local procedures for validation test equipment compliance.
• Ensure training of employees in software and test equipment validation.
• Establish Validation Master Plan for software and equipment re-validation.

Conocimientos

Statistical Techniques

Risk Assessment

Validation Process

English Proficiency

Microsoft Proficiency

Educación

Bachelor’s degree in Industrial Engineering

Bachelor’s degree in Process Engineering

Descripción del empleo

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com

About the role

Ensure systems for Software, test method and process equipment validation are following current regulations and procedures already in place.

Key responsibilities

1. Establish/maintain necessary local procedures, instructions, and forms for validation test equipment in compliance with current BUID procedures for process validation and relevant quality standards, incl. GHTF (Global Harmonization Task Force) guidelines for process validation.
2. Establish/maintain VMP (Validation Master Plan) for re-validation of software, test equipment & method, incl. validation history and ensure it is approved by and communicated to relevant areas.
3. In cooperation with the Maintenance, Production and Eng. Department ensure resource planning for revalidation activities.
4. Ensure necessary training of employees in software, test equipment and method validation.

Requirements:

1. Bachelor’s degree in Industrial Engineering, Process Engineering or related.
2. Approximately 2 years of experience working with validation process, calibrations and risk assessment.
3. Basic knowledge and experience of statistic techniques is required.
4. English proficiency: Intermediate - Advanced.
5. Microsoft proficiency: Intermediate - Advanced.

Equal opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.