CQV Engineer (Commissioning, Qualification, and Validation)

Title: CQV Engineer (Commissioning, Qualification, and Validation)

Location: Brooklyn, NY (Hybrid – 3 days onsite per week)
Contract Duration: 6 to 12 months (with possible extension)
Experience Needed: 5 years in CQV within pharmaceutical or life sciences manufacturing
 

Job Description:

Client is hiring a CQV Engineer for a hybrid role based in New York. This role will focus on Commissioning, Qualification, and Validation of automated pharmaceutical manufacturing equipment. The candidate will be expected to drive equipment qualification, perform detailed risk assessments, author SOPs from scratch, and lead deviation and CAPA investigations in compliance with FDA and GMP standards.

Roles and Responsibilities:

·       Lead and execute commissioning, qualification, and validation efforts for automated manufacturing systems.

·       Draft and revise Standard Operating Procedures (SOPs) to ensure regulatory and process compliance.

·       Conduct risk assessments such as FMEA and implement necessary mitigations.

·       Manage deviation investigations and develop appropriate CAPAs.

·       Ensure all documentation aligns with regulatory standards including 21 CFR Part 11 and GAMP guidelines.

·       Collaborate with cross-functional teams including Quality, Manufacturing, and Engineering.

Must Haves:

·       Hands-on experience with automated pharmaceutical manufacturing equipment.

·       Strong understanding of risk management practices and deviation handling.

·       Demonstrated ability to create SOPs from scratch.

·       Experience working within GMP-regulated environments.

·       Experience investigating deviations and CAPAs (Corrective and Preventive Actions)

Skills Required:

·       Risk Assessment (FMEA)

·       SOP Writing

·       Deviation and CAPA Management

·       Automated Manufacturing Systems

·       GAMP 5

·       21 CFR Part 11 Compliance

TOP 3:

·       CQV experience with automated pharmaceutical equipment

·       SOP development and documentation skills

·       Risk assessments and deviation/CAPA handling expertise