Roles & Responsibilities
We are seeking a QC Engineer with hands-on experience in temperature mapping of controlled chambers. The role focuses on validation, documentation, and compliance with GDP and ALCOA+ principles to ensure the reliability of temperature-controlled environments in a regulated setting.
Key Responsibilities
- Plan and execute temperature mapping studies for chambers such as cold rooms, freezers, incubators, and stability chambers.
- Prepare and review protocols, reports, and validation deliverables using systems such as Kneat .
- Perform data integrity assessments and ensure compliance with GDP and ALCOA+ principles.
- Draft, review, and maintain SOPs related to temperature mapping and qualification activities.
- Support audit / inspection readiness through accurate documentation and reporting.
- Collaborate with QC, QA, and Engineering teams to ensure compliance and operational readiness.
- Contribute to process improvements for chamber qualification and environmental monitoring.
Requirements
Bachelor’s degree or Diploma in Life Sciences, Engineering, or related discipline.2–5 years’ experience in temperature mapping of chambers within pharmaceutical / biotech or regulated industries.Knowledge of GDP, ALCOA+ principles , and validation requirements.Experience with protocol drafting and use of electronic validation systems (e.g., Kneat) is advantageous.Strong analytical and documentation skills.Ability to work cross-functionally and support compliance initiatives.Tell employers what skills you have
temperature readings
temperature sensors
GMP
validation protocols
Temperature Controlled
Clinical Protocols
Biotechnology
Compliance
Qualification Testing
Equipment Qualification
Audits
monitoring of temperature
Temperature Measurement
test protocols
Regulatory Requirements
Life Sciences
temperature gradients,
Commissioning