Validation Engineer (m/f/x)

Coloplast; Felgueiras; On-site; EUR 42,000 - 65,000; Full time

Job summary

Coloplast in Portugal is seeking a Validation Engineer to drive process and software validation activities and maintain the validation life cycle of machines, processes, and test methods in alignment with the quality management system.

Responsibilities include issuing/approving validation documentation, IQ/OQ/PQ of equipment, software validation, risk assessments, and cross-functional support for new machines and transfers to ensure compliance and continuous quality improvement.

Qualifications

• Cross-functional: self-management, decision making, collaboration and communication.
• Fluent in both spoken and written English.
• B.Sc. or M.Sc. in a relevant field or production/quality experience with related courses.
• Structured and systematic; able to work independently.

Responsibilities

• Issuing, completing, or approving validation documentation (protocols, deviations, reports).
• Performing IQ/OQ/PQ of equipment, instruments, and machines.
• Performing validation of test methods for continues data and attributes.
• Assessing software changes and validating software as appropriate.
• Creating software validation plans and validation strategic plans.
• Issuing, updating, and approving Process Risk assessments.
• Investigating abnormal test results in collaboration with Quality and Production teams.
• Troubleshooting validation issues with stakeholders.
• Collecting, organizing, and documenting test data; statistical analysis of data.
• Maintaining validation documentation throughout the life cycle; supporting cross-functional projects.

Job description

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The Validation Engineer will be responsible for the execution of process and software validation activities under the
organizations as well as maintaining the validation life cycle of the machines, process, and test method, ensure
compliance within external and internal requirements and ensure compliance with the quality management system.

Major areas of accountability

• Performing their job in compliance with the guidelines given;
• Drawing attention to the manager to any difficulties in understanding or following the guidelines;
• Drawing attention to inefficiency of the system;
• Ensure continuous improvement of processes & specifications;
• Provide sparring and support for Operations in CMPT regarding quality issues and help improve overall quality understanding during validations;
• External / internal Audit support;
• Maintain high quality understanding in operations through support and guidance of operators daily;

Essential Duties / Responsibilities
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:

• Issuing, completing, or approving validation documentation (protocols, deviations, reports, etc.);
• Performing Installation, Operational, and Performance Qualification of equipment, instruments, and machines;
• Performing validation of test methods for continues data and attributes;
• Performing assessment about software changes and perform validation of software as appropriate;
• Creation of software validation plans and validation strategic plans as required;
• Issuing, updating, and approving Process Risk assessments;
• Investigating abnormal test results (close collaboration with Quality Engineer and Production Support Engineers and stakeholders);
• Troubleshooting validation issues (close collaboration with Quality Engineer and Production Support Engineers and stakeholders);
• Handling of Process validation, Software validation and Risk assessments related Change Request tasks;
• Collecting, organizing, and documenting test data;
• Statistical analysis of data for process and test methods validation;
• Ensuring accurate records of all validation activities.
• Maintaining validation documentation throughout the validation life cycle.
• Participation on cross-functional teams related to projects for new machines, transfer machines, item extensions or any other project where validation assessment or validation activity is needed;
• Drawing attention to the manager to any difficulties in understanding or following the guidelines;
• Drawing attention to inefficiency of the system;
• Take responsibility for those safety aspects identified for the given position.

Department :

• Support Validation Training in FEL Quality

Required knowledge, skills & abilities

• Cross-functional: Self-management, decision making and critical thinking, collaboration & communication.
• Functional competencies: Coloplast specific knowledge of quality management system and processes.
• Fluent in both spoken and written English
• Newly graduated with a B.Sc., or a M.Sc., or experience in production with quality focus or quality roles combined with relevant courses
• 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