Validation Engineer - Process & Software Validation

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

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.