Senior CQV Engineer: Parallel Manufacturing Enablement

ProQuality Network; United States; Hybrid; USD 140,000 - 190,000; Full time

Job summary

ProQuality Network seeks an experienced Senior CQV Engineer for a Parallel Manufacturing Enablement Project in an on-site setting east of Puerto Rico. You will lead and execute CQV activities for new manufacturing equipment integration, ensuring regulatory compliance and robust validation programs.

The role requires extensive CQV experience within pharma/biotech, strong GMP knowledge, and proven project leadership to deliver documentation-ready results for audits and inspections.

Qualifications

• Extensive CQV lifecycle experience in pharma/biotech environments.
• Strong knowledge of cGMP regulations and change control processes.
• Experience supporting FAT/SAT and SIP validation activities.
• Excellent technical writing, documentation, and audit readiness skills.
• Proven project leadership capabilities across cross-functional teams.

Responsibilities

• Develop CQV plans and reports for the validation lifecycle.
• Review URS and FAT documentation; support FAT execution.
• Coordinate FAT/SAT activities with vendors and site teams.
• Ensure compliance with site SOPs and regulatory standards.
• Maintain traceability from URS through qualification deliverables.
• Lead multiple CQV activities to meet project deadlines.

Skills

CQV

cGMP

Regulatory compliance

Project management

Documentation

FAT/SAT

Validation engineering

FDA inspections

Vendor coordination

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate degree

Job description

ProQuality Network seeks an experienced Senior CQV Engineer for a Parallel Manufacturing Enablement Project in an on-site setting east of Puerto Rico. You will lead and execute CQV activities for new manufacturing equipment integration, ensuring regulatory compliance and robust validation programs.

The role requires extensive CQV experience within pharma/biotech, strong GMP knowledge, and proven project leadership to deliver documentation-ready results for audits and inspections.