Validation Engineering - Katalyst Healthcares & Life Sciences
Marlborough, MA 01752
About the Job
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.
Requirements:
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.