What are the responsibilities and job description for the Senior CQV Engineer position at Intellectt Inc?
Job Title : Senior CQV Engineer
Location : New York, NY
Job Description :
Our client, a leading organization in the medical device / pharmaceutical industry , is seeking an experienced Senior CQV (Commissioning, Qualification, and Validation) Engineer to lead validation activities for new and existing facilities, equipment, and processes. The ideal candidate will have a strong background in CQV methodologies, regulatory compliance, and hands-on execution of validation protocols.
Key Responsibilities :
- Develop and execute CQV strategies , including commissioning, qualification (IQ, OQ, PQ), and validation of equipment, utilities, and processes .
- Ensure compliance with FDA, cGMP, GAMP 5, and ISO 13485 regulations.
- Author, review, and approve CQV documentation , including protocols, reports, risk assessments, and deviations.
- Lead process validation (PV), cleaning validation (CV), and equipment validation (EV) efforts.
- Support facility start-up, FAT, SAT, and technology transfer activities.
- Collaborate with engineering, manufacturing, quality, and regulatory teams to drive validation projects.
- Identify and implement continuous improvements in CQV processes.
- Provide technical leadership and mentorship to junior engineers.
Required Skills & Qualifications :
Preferred Qualifications :
Benefits & Perks :
