Validation Engineer II

About Convatec

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 more than 10000 colleagues we provide our products and services in around 90 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. Convatecs revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit

Position Overview:

The Validation Engineer will participate in the process development of projects related with capacity upgrade of existing products and processes R/D for new products update of existing products and Revalidation Process Manufacturing.

Key Responsibilities:

Technical project documentation and activities:

Participate in Change Control Process (CCRs) for new projects involving the
Project Engineering Department.
Develop establish maintain modify and handle the technical project
documentation according to BUIC DK/ UMID MX process development procedure
Participate in gathering the necessary documentation for closure of CCRs
Create develop and conduct process validation activities.
Coordinate production runs test runs and any other related activities to process
validations.
Initial validation of new process equipment if required based on risk assessment.
Re-validation method and frequency as defined (VMP).
Regular follow up on re-validation plans and that re-validation is performed (VMP).
Assure proper review / approval of validation documentation.

Quality documentation and activities:
Participate in writing Process FMECA (P-FMECA)
Responsible for documentation- and performing Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) in cooperation with the BUIC DK/ UMID MX project team and other relevant SMEs e.g. other involved project managers andproduction sites.
Create validation documentation for New processes tools machines and materials according to localprocedures.
Transferred projects.
Re-validation according to instructions and forms for process validationrelevant P-FMECAs and other relevant documents.
Perform validation based on above documents in cooperation with the BUIC DKand/or UMID MX project team and if relevant other involved parties e.g. projectmanagers and other production sites.
Perform necessary training of employees participating in validation activities.

About you:

Skills and Experience:

About 3 years of experience in similar position.

Experience with performing risk analysis.

Experience with validation of process equipment.

Knowledge of the basic requirements of the FDA QSR GMP GAMP ISO13485 and ISO11607-2.

Basic knowledge in Minitab.

Advanced knowledge of Excel (pivot tables graphs formulas macros etc.)

Qualifications/Education:

Bachelors Degree in Industrial Engineering Mechatronics Electronics Mechanical Engineering or a related field.

What youll get:

Competitive salary bonus

Training & development

Collaborative supportive culture

Ready to join us

At Convatec were pioneering trusted medical solutions to improve the lives we touch. If youre ready to make a real impact apply today and help us bring our Forever Caring promise to life.

Qualifications & Education:

Professional Degree required.

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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.

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