Software, test equipment and method validation engineer
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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 convatec group.
about the role
ensure systems for software, test method and process equipment validation are following current regulations and procedures already in place.
key responsibilities
* 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.
* 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.
* in cooperation with the maintenance, production and eng. Department ensure resource planning for revalidation activities.
* ensure necessary training of employees in software, test equipment and method validation.
requirements:
* bachelor’s degree in industrial engineering, process engineering or related.
* approximately 2 years of experience working with validation process, calibrations and risk assessment.
* basic knowledge and experience of statistic techniques is required.
* english proficiency: intermediate - advanced.
* 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.
seniority level
entry level
employment type
full-time
job function
quality assurance
industries
medical equipment manufacturing
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