Hands-On Test Method & Equipment Specialist

Coloplast A/S; Denmark; On-site; DKK 600,000 - 820,000; Full time

Job summary

Coloplast A/S seeks a Test Method Specialist to act as the technical focal point for selected test methods and equipment in the Pilot Plant in Mørdrup, Denmark. You will troubleshoot, qualify, calibrate and upgrade equipment, while ensuring data traceability and compliant laboratory processes throughout the product lifecycle.

You will work closely with QA Lifecycle Laboratory and international manufacturing sites, coordinating improvements, audits and transfers, with strong stakeholder

Qualifications

• Master’s degree in science/engineering/technical field or 5+ years of relevant experience with test methods
• Hands-on experience with test methods and qualification of laboratory or production equipment
• Strong problem-solving skills and structured root cause analysis
• Confident evaluating and presenting technical data, including statistical methods
• Ability to write and interpret technical documentation, protocols and reports
• Knowledge of quality systems; ISO 9001/13485 and GMP understanding is advantageous
• Able to plan, prioritise work and see activities to completion
• Excellent stakeholder management across functions, sites and suppliers
• Proficient English; Danish is an advantage
• Experience with digital tools for documentation and traceability (Microsoft Office, Veeva, JMP)

Responsibilities

• Acting as technical owner and contact for test methods and equipment
• Plan, coordinate and perform qualification of test equipment, including relocations and replacements
• Prepare and maintain qualification protocols, reports and test method documentation
• Troubleshoot test equipment and methods; lead root cause investigations
• Ensure calibration, servicing, preventive maintenance and proper data traceability
• Handle changes, nonconformities and CAPAs related to test methods and equipment
• Support data handling and traceability before product release
• Coordinate transfers of methods/equipment to international sites
• Provide technical support to Pilot Plant, Global Operations and manufacturers
• Collaborate with Global Test Method teams on method development and improvements
• Train staff in test methods and equipment usage
• Coordinate software/PC upgrades and manage suppliers and service agreements
• Participate in audits related to test methods and equipment
• Contribute to continuous improvement of lab processes and systems

Skills

Test methods

Root cause analysis

Data analysis

Stakeholder management

Quality systems

Documentation

English communication

Education

Master's degree in science/engineering/physics/chemistry/pharmacy

Tools

Veeva

JMP

Office software

Job description

Coloplast A/S seeks a Test Method Specialist to act as the technical focal point for selected test methods and equipment in the Pilot Plant in Mørdrup, Denmark. You will troubleshoot, qualify, calibrate and upgrade equipment, while ensuring data traceability and compliant laboratory processes throughout the product lifecycle.

You will work closely with QA Lifecycle Laboratory and international manufacturing sites, coordinating improvements, audits and transfers, with strong stakeholder