Job Description

Validation & Engineering Group, Inc., a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethical standards for the following position:

• Turnover Package (TOP) Coordinator

The Turnover Package (TOP) Coordinator / Documentation Engineer will serve as the primary interface between Construction, Equipment Vendors, Engineering, CQV, and Quality teams to ensure all turnover documentation packages are complete, accurate, and compliant prior to release for commissioning and qualification activities.

This role is responsible for ensuring turnover packages are technically sound, aligned with approved system boundaries, and compliant with site GDP, GMP, and validation requirements before execution of Commissioning and IQ activities begins.

The objective of the role is to provide CQV and Validation teams with turnover documentation packages that have already undergone a structured technical, documentation, and compliance review process to support efficient system startup and qualification execution.

Key Responsibilities:

1. 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

2. Coordination & Interface Management

• Serve as liaison between Construction, Vendors, Engineering, CQV, Validation, and QA teams
• 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

3. Field & Technical Support

• Participate in system walkdowns to verify field installation aligns with approved drawings and design documentation
• Support development and tracking of punch list items related to turnover and documentation deficiencies
• Assist with identification, categorization, and resolution of closeout issues impacting system acceptance
• Support final turnover walkdowns and package acceptance activities with project stakeholders
• Interface with field teams to ensure timely collection and reconciliation of as-built documentation

4. Tracking, Reporting & Closeout

• Maintain turnover package trackers, system status reports, and documentation metrics
• Monitor turnover readiness and communicate status, risks, and critical gaps to project leadership
• 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

Required 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

Preferred Qualifications

• Experience supporting large capital projects, facility expansions, or startup activities
• Familiarity with turnover management systems and electronic documentation platforms
• Experience supporting CQV lifecycle execution within regulated manufacturing environments
• Knowledge of ASTM, ISPE, or commissioning and qualification best practices
• Previous experience coordinating turnover activities on EPCM or construction-driven projects

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

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