Katalyst Healthcares and Life Sciences
Responsibilities:
- TCU Mapping Protocols: Conduct and document temperature mapping activities to ensure that Temperature Control Units (TCUs) comply with regulatory and operational standards.
- Protocol Support: Assist in the development and execution of validation protocols, ensuring alignment with both internal and regulatory requirements.
- Data Collection & Analysis: Support the collection and initial analysis of TCU mapping data to aid in validation reporting and quality control.
- Collaboration & Learning: Work under the guidance of a senior engineer and gain mentorship while preparing for potential leadership responsibilities.
- Ensure Compliance: Support the maintenance of GMP, safety, and quality standards during all mapping activities.
- 5-6 years of experience as a Validation Engineer, preferably within regulated industries such as life sciences or pharmaceuticals.
- Strong Experience with equipment like TCUs and temperature mapping.
- Experience with Quality Control (QC) analytical methods.
- Bachelor's degree in engineering, chemistry, or a related technical field.
- Adhere to temperature mapping, calibration, and related validation protocols.
- Strong attention to detail and analytical skills for reviewing data and ensuring protocol compliance.
- A willingness to learn, work collaboratively within a team, and develop communication skills under mentorship.
- LIMS, Track Wise, TruScan, Gas Chromatography, Spectrophotometers (current & new printer), TCU, Endo scan.