Turnover Documentation Lead for Validation Projects

Validation & Engineering Group, Inc.; Wilson (NC); On-site; USD 70,000 - 100,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a Turnover Package (TOP) Coordinator / Documentation Engineer to serve as the primary interface between Construction, Equipment Vendors, Engineering, CQV, and Quality teams, ensuring turnover documentation packages are complete, accurate, and compliant before commissioning and IQ activities begin.

The role emphasizes alignment with approved system boundaries, GDP/GMP standards, and validated documentation practices to support startup readiness and

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

• Turnover Package Review & Compliance
• Review turnover packages prepared by General Contractors, subcontractors, integrators, and equipment vendors for completeness, accuracy, and compliance
• Verify documentation aligns with approved system boundaries, turnover strategy, and validation plans
• Ensure turnover packages adequately support commissioning, startup, and qualification readiness activities
• Confirm compliance with site GDP, GMP, and documentation control requirements
• Verify inclusion and accuracy of required supporting documentation, including: redlined drawings, inspection and test records, material certificates, calibration records, weld documentation, FAT/SAT documentation, vendor manuals and turnover deliverables
• Ensure electronic turnover files are properly structured, indexed, and maintained within designated project repositories and document management systems
• Support turnover package standardization and continuous improvement initiatives
• Coordinate turnover documentation expectations, submission requirements, and revision control processes with contractors and vendors
• Facilitate resolution of documentation deficiencies, punch items, and gaps prior to turnover acceptance
• Work with SMEs and system owners to define and finalize system boundaries and turnover scope
• Align turnover activities with construction completion milestones, startup sequencing, and validation schedules
• Participate in turnover planning meetings and project coordination sessions
• Interface with field teams to ensure timely collection and reconciliation of as-built documentation
• Develop and track punch lists for missing, incomplete, or deficient documentation through closure
• Support formal turnover package assembly, approval routing, and transmittal processes
• Assist with project closeout activities and final documentation reconciliation

Job description

Validation & Engineering Group, Inc. seeks a Turnover Package (TOP) Coordinator / Documentation Engineer to serve as the primary interface between Construction, Equipment Vendors, Engineering, CQV, and Quality teams, ensuring turnover documentation packages are complete, accurate, and compliant before commissioning and IQ activities begin.

The role emphasizes alignment with approved system boundaries, GDP/GMP standards, and validated documentation practices to support startup readiness and