Validation Technician

Coloplast; Felgueiras; On-site; EUR 32,000 - 52,000; Full time

Job summary

Coloplast is seeking a Validation Technician in Felgueiras, Portugal to support validation strategy and uphold a quality mindset on site. You will assist Operations during process validations and ensure adherence to the Quality Management System, contributing to continuous improvement and quality understanding across teams.

Responsibilities include documentation, training material preparation, and active involvement in validation of machines, processes, and equipment.

Qualifications

• Fluent in English (spoken and written).
• Experience in production with quality focus or quality roles.
• Structured and systematic approach.
• Ability to work independently.

Responsibilities

• Support Operations during process validations.
• Ensure compliance with Coloplast Quality Management System for process validations.
• Assist in continuous improvement of processes and specifications.
• Provide sparring and support to Operations in CMPT regarding quality issues.
• Audit support (internal/external).
• Guide operators during validation.

Skills

Self-management

Critical thinking

Collaboration

Communication

Job description

As the Validation Technician in Quality in Felgueiras, Portugal (FEL), you are responsible for supporting the validation strategy and quality mindset is implemented on site in FEL, support Operations during process validations.

Major areas of accountability

• Ensure Operations support within Validation related topics and challenges.
• Ensure compliance with Coloplast Quality Management system for Process validations.
• Ensure continuous improvement of processes & specifications.
• Provide sparring and support to Operations in CMPT regarding quality issues and help improve overall quality understanding in connection with process validations.
• External / internal Audit support.
• Maintain high quality understanding in operations through support and guidance of operators during validation.

Below duties & responsibilities apply when the site opens for production or when applicable training is performed for each of the topics where such training is required.

General:

• Managing and registering the documentation of the validation system;
• Professional advice and supervision for validation engineers and other partner departments and functions;
• Participating in the control and monitoring of the technical introduction of new products;
• Participation in the installation and commissioning of new production equipment and production lines, control of machine and quality indicators and processes, and certification;
• Participation in the validation of machines and processes; o Preparation and filling in of validation protocols, checking the documentation required for the completion of validation;
• Organization of trainings, preparation of training materials for production operators in connection with validation o Work discipline must be observed and enforced;
• On the instructions of their superiors at the workplace or on their own initiative, they must also perform occasional tasks that are not specified in the job description, but which can be determined from the purpose of the job as part of their field of activity, or arise from an emergency, or are an ancillary part of the job.

Required knowledge, skills & abilities

• Cross-functional: Self-management, critical thinking, collaboration & communication.
• Functional competencies: Coloplast specific knowledge of quality management system and processes.
• Fluent in both spoken and written English
• Experience in production with quality focus or quality roles
• Good English skills in verbal and written form
• Structured and systematic
• Conducting own work independently

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

Coloplast Group - Holtedam 1 - Humlebaek - DK 3050 - Denmark