Software Validation Manager (Specialist)

You will be responsible for the following tasks:

• leading global compliance for software validation in automated manufacturing processes,
• developing and maintaining  SOPs, instructions, templates, and training materials for software validation in automated manufacturing processes,
• setting the direction for software validation in both product development and manufacturing environments, including maintaining validated states for production software,
• evaluating and guiding machine builders and suppliers to meet Coloplast’s software validation expectations,
• ensuring global training structures and supporting users across sites,
• driving continuous improvement initiatives and process enhancements,
• supporting audits and maintaining readiness for both internal and external assessments,
• supporting statistical tools for capability analysis and reporting.

You are the ideal candidate if:

• fluent English communication skills,
• solid experience with software validation in manufacturing environments,
• experience working with process risk management and process validation,
• an ability to work methodically, solve problems systematically, and challenge existing structures when better solutions exist,
• a relevant academic background or equivalent hands‑on experience,
• strong IT skills, including Microsoft Office.

It is an adventage if:

• experience working with systems and processes supporting operations/manufacturing,
• knowledge of legislation, standards, and industry expectations related to software in automated processes,
• statistical skills.

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.

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