CQV Engineer

Trimah Technologies is seeking a highly motivated and skilled CQV Engineer to join our team. This role focuses on ensuring the quality and compliance of critical utilities and processes in our manufacturing and production environments. The ideal candidate will have experience with autoclave cycle development, PQ (Performance Qualification) execution, and risk assessments, contributing to maintaining a safe and efficient operational setup.Role accountabilities:Autoclave Cycle Development and PQ:Develop and optimize autoclave cycles for the sterilization process to meet regulatory and operational requirements.Lead and support Performance Qualification (PQ) for autoclaves to ensure proper function, validation, and compliance.Collaborate with engineering teams on design, manufacturing, and commissioning of autoclaves.Define User Requirement Specifications (URS) and Functional Specifications (FS) .Develop PQ protocolsPrepare PQ reports and support regulatory inspections.Qualifications & Experience:Bachelor's degree in engineering, Life Sciences, or a related field.Proven experience in autoclave cycle development and PQ execution.Strong knowledge of environmental monitoring, risk assessments, and utility qualification (WFI, compressed air, CO2, O2).Familiarity with industry standards and regulatory guidelines (e.g., GMP, FDA, ISO).Excellent problem-solving, communication, and documentation skills.Ability to work effectively within a cross-functional team.Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation.

Created: 2025-02-22