We are looking for a QC engineer with hands-on expertise in temperature mapping of controlled chambers. The role supports qualification documentation and lifecycle compliance of temperature-controlled environments in a GMP-regulated setting.
Key Responsibilities
- Plan execute and document temperature mapping studies for chambers (cold rooms freezers incubators stability chambers).
- Prepare and review validation protocols reports and deliverables in Kneat or equivalent systems.
- Perform data integrity assessments and ensure compliance with GDP and ALCOA principles.
- Draft and maintain SOPs for temperature mapping and chamber qualification.
- Support deviation management change control and CAPA implementation.
- Provide technical input for requalification planning and continuous improvement.
- Collaborate with QC QA and Engineering to support audit and inspection readiness.
Requirements
- Bachelors 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 qualification practices.
- Familiarity with mapping across a variety of chambers is advantageous.
- Experience with validation documentation and use of Kneat preferred.
- Strong technical writing data review and teamwork skills.
We are looking for a QC engineer with hands-on expertise in temperature mapping of controlled chambers. The role supports qualification documentation and lifecycle compliance of temperature-controlled environments in a GMP-regulated setting. Key Responsibilities Plan execute and document temperatur...
We are looking for a QC engineer with hands-on expertise in temperature mapping of controlled chambers. The role supports qualification documentation and lifecycle compliance of temperature-controlled environments in a GMP-regulated setting.
Key Responsibilities
- Plan execute and document temperature mapping studies for chambers (cold rooms freezers incubators stability chambers).
- Prepare and review validation protocols reports and deliverables in Kneat or equivalent systems.
- Perform data integrity assessments and ensure compliance with GDP and ALCOA principles.
- Draft and maintain SOPs for temperature mapping and chamber qualification.
- Support deviation management change control and CAPA implementation.
- Provide technical input for requalification planning and continuous improvement.
- Collaborate with QC QA and Engineering to support audit and inspection readiness.
Requirements
- Bachelors 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 qualification practices.
- Familiarity with mapping across a variety of chambers is advantageous.
- Experience with validation documentation and use of Kneat preferred.
- Strong technical writing data review and teamwork skills.
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