Turnover Documentation Lead (CQV/Validation)

Pinnaql, Inc.; Wilson (NC); On-site; USD 70,000 - 90,000; Full time

Job summary

Validation & Engineering Group, Inc., a Pinnaql company, seeks a Turnover Package Coordinator / Documentation Engineer to interface with Construction, Vendors, Engineering, CQV, Validation, and QA teams. You will ensure turnover documentation is complete, accurate, and compliant prior to commissioning and IQ activities.

The role requires reviewing documents for GDP/GMP alignment, system boundaries, and validation plans.

Qualifications

• Experience supporting GxP-regulated pharmaceutical, biotech, or medical device projects.
• Strong understanding of Commissioning, Qualification, Validation, and turnover documentation processes.
• Experience reviewing vendor, construction, and engineering turnover documentation packages.
• Ability to read and interpret P&IDs, isometrics, engineering drawings, and technical specifications.
• Working knowledge of GDP, GMP, and documentation management practices.
• Experience participating in system walkdowns, punch list management, and closeout activities.
• Strong coordination and cross-functional communication skills.
• Ability to manage multiple priorities in fast-paced project environments.
• Proficiency with Microsoft Office applications and document management systems.

Responsibilities

• Review turnover packages for completeness, accuracy, and compliance.
• Coordinate turnover documentation expectations with contractors and vendors.
• Interface with Construction, Vendors, Engineering, CQV, Validation, and QA teams.
• Maintain turnover package trackers, status reports, and documentation metrics.

Skills

Coordination

Cross-functional communication

GxP experience

Microsoft Office

Document management systems

Tools

Document management systems

Job description

Validation & Engineering Group, Inc., a Pinnaql company, seeks a Turnover Package Coordinator / Documentation Engineer to interface with Construction, Vendors, Engineering, CQV, Validation, and QA teams. You will ensure turnover documentation is complete, accurate, and compliant prior to commissioning and IQ activities.

The role requires reviewing documents for GDP/GMP alignment, system boundaries, and validation plans.