GMP Validation Consultant: Qualification & Temp Mapping (6-mo)

Planet Pharma; Hillerød; On-site; DKK 600,000 - 720,000; Part time

Job summary

Planet Pharma is seeking an experienced Validation Consultant for a six-month, part-time contract to support qualification and temperature mapping across GMP-regulated environments. The role involves ownership of qualification activities, data logger deployment, and collaboration with Quality, Engineering and external vendors to deliver timely results.

The candidate will author and execute qualification protocols, analyze data, and contribute to deviations and investigations in a controlled

Qualifications

• Proven GMP qualification and validation experience in pharmaceutical/biotech or regulated life sciences.
• Hands-on temperature mapping and qualification of cold storage equipment.
• Experience supporting N? or cryogenic storage systems and warehouse mapping.
• Strong knowledge of study design, data logger deployment and data analysis.
• Experience authoring and executing qualification protocols and reports.
• Understanding of challenge testing including power loss, door/opening, alarms.
• Experience managing deviations, investigations and change controls within GMP.
• Solid understanding of GMP, GDP, data integrity and controlled documentation.

Responsibilities

• Plan and execute qualification, requalification and temperature mapping studies.
• Prepare and update protocols, test requirements and acceptance criteria.
• Execute protocols including data logger deployment, retrieval and testing.
• Analyse qualification and mapping data against acceptance criteria.
• Produce final reports, recommendations and qualification documentation.
• Support deviations, investigations and change control activities.
• Contribute to qualification activities for new installations, modifications, relocations and repairs.
• Coordinate with Quality, Engineering, Validation, Facilities, Operations and external vendors to ensure timely delivery.

Skills

GMP qualification

Validation experience

Temperature mapping

Data loggers

Protocol execution

Deviations & change control

GMP/GDP knowledge

Independent worker

Education

Bachelor's degree in Engineering

Bachelor's degree in Biotechnology

Bachelor's degree in Life Sciences

Tools

Data loggers

Temperature mapping tools

Job description

Planet Pharma is seeking an experienced Validation Consultant for a six-month, part-time contract to support qualification and temperature mapping across GMP-regulated environments. The role involves ownership of qualification activities, data logger deployment, and collaboration with Quality, Engineering and external vendors to deliver timely results.

The candidate will author and execute qualification protocols, analyze data, and contribute to deviations and investigations in a controlled