Validation Consultant – Requalification & Temperature Mapping

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

Contract l 6 months l part-time

A leading biotechnology manufacturing organisation is seeking an experienced Validation Consultant to support a major qualification and temperature mapping programme within a GMP regulated environment.

This is a project based contract opportunity supporting qualification, requalification and temperature mapping activities across a range of controlled temperature units and storage areas.

The Role

You will take ownership of qualification and temperature mapping activities, ensuring equipment and storage environments meet GMP standards and operational requirements.

Key responsibilities include:

• Planning and executing qualification, requalification and temperature mapping studies
• Preparing and updating protocols, test requirements and acceptance criteria
• Conducting protocol execution including data logger placement, retrieval and challenge testing
• Analysing qualification and mapping data against predefined acceptance criteria
• Producing final reports, recommendations and qualification documentation
• Supporting deviations, investigations and change control activities
• Contributing to qualification activities associated with new installations, modifications, relocations and repairs
• Coordinating with Quality, Engineering, Validation, Facilities, Operations and external vendors to ensure timely project delivery

Requirements

To be successful in this role, you should possess:

• Proven GMP qualification and validation experience within the pharmaceutical, biotechnology or other regulated life science sector
• Hands on experience with temperature mapping and qualification of cold rooms, incubators, refrigerators and freezers
• Experience supporting N? or cryogenic storage systems and warehouse mapping activities
• Strong knowledge of temperature mapping study design, data logger deployment and data analysis
• Experience authoring and executing qualification protocols and reports
• Understanding of challenge testing including power failure recovery, door opening and alarm verification studies
• Experience managing deviations, investigations and change controls within a GMP quality system
• Solid understanding of GMP, GDP, data integrity and controlled documentation practices
• Ability to work independently and drive activities through to completion

Candidate Profile

• Strong technical writing and documentation skills
• Highly organised with excellent attention to detail
• Analytical and methodical approach to problem solving
• Effective stakeholder management and communication skills
• Capable of managing multiple priorities in a fast paced project environment
• Self motivated and delivery focused

Education

• Bachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, Life Sciences or a related technical discipline
• Extensive relevant industry experience will also be considered
• Previous GMP qualification and validation experience is essential