C&Q Engineer

Summary: This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in handling day-to-day activities inclusive of execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manufa

Summary : This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in handling day-to-day activities inclusive of execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manuf

Roles & Responsibilities Lead end-to-end CSV activities (inventory assessment remediation disposition) Support business separation for large GxP systems Define & implement risk-based validation strategies Review & approve test plans, UAT scripts, validation documents Ensure compliance with regulatory & quality standards Provide guidance, escalation & leadership to validation teams Collaborate with global & remote teams Education & Experience : 7-10 years in CSV / Validation roles Experience in P

HMG America LLC is the best Business Solutions focused Information Technology Company with IT consulting and services, software and web development, staff augmentation and other professional services. One of our direct clients is looking for Validation PMO in Raritan, NJ. Below is the detailed job description. Job Title - Validation PMO Location Raritan, NJ(Hybrid) Job Responsibility: Experience in the Pharmaceutical, biotechnology, or medical device industry 2+ years' experience with System