TOP Documentation Specialist

Job Description

Validation & Engineering Group, Inc. (V&EG) 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 ethics standards for the following position:

TOP Documentation Specialist

The TOP Documentation Specialist is responsible for the collection, review, organization, and delivery of Turnover Packages (TOPs) for all packaging line equipment, systems, and supporting utilities within a GMP-regulated biotechnology site.

This role ensures that all engineering, commissioning, qualification, and vendor documents are accurate, complete, and compliant with site standards, FDA/EMA regulations, and project milestones for system handover to Operations and Quality.Key Responsibilities:Turnover Package Management

Develop and maintain the TOP index, trackers, and matrix for all packaging lines and supporting systems (e.g., filling, labeling, cartoning, serialization, aggregation, utilities).

Coordinate with Engineering, Commissioning (Cx), Validation (CQV), Quality, and Construction teams to ensure all required records are submitted on time.

Collect and compile key documents, including:

URS, BOD, design drawings, vendor manuals, material certifications, weld maps, FAT/SAT, IQ/OQ/PQ, calibration reports, EHS certifications, and training records.

Review all documents for accuracy, revision control, signatures, and GMP compliance before final handover.Compliance & Documentation Control

Ensure all TOP documentation complies with GMP, FDA 21 CFR Part 11, GAMP 5, and data integrity requirements.

Support audit readiness by maintaining organized, retrievable, and secure records (electronic and hard copy).

Work with the Quality Unit to ensure final TOP approval and proper archiving into the site’s document control system (e.g., Veeva, Documentum, or MasterControl).Project Support & Coordination

Act as the central point of contact for document status, gaps, and deadlines for turnover deliverables.

Support engineering change controls, redlining of P&IDs/drawings, and transmittal logs as needed.

Prepare weekly progress reports on TOP completion percentages and outstanding items for project leadership.

Assist in the development of standard templates, workflows, and lessons learned to improve future turnover execution.Qualifications:

Required:

Associate or Bachelor’s degree in Engineering, Technical Sciences, or Document Control/Information Management (or equivalent experience).

3+ years of experience in TOP/document control in a GMP pharmaceutical, biotech, or regulated construction project environment.

Strong understanding of GMP documentation, Cx/Qx deliverables, validation protocols, and FDA/EMA compliance.

Proficiency with MS Excel/Word, PDF markup, and document control software (Veeva, MasterControl, Documentum, SharePoint).

Strong organizational skills with attention to detail, version control, and deadlines.

Preferred:

Experience supporting packaging line installation and turnover in biotech or pharmaceutical facilities.

Familiarity with Kneat or other e-CQV platforms for commissioning/qualification documentation.

Knowledge of LEED commissioning and sustainability-related documentation for energy and atmosphere credits.

Excellent communication and stakeholder coordination skills.Core Competencies:

Attention to Detail & Data Integrity – Ensures every record is audit-ready.

Organizational Excellence – Manages large volumes of documents across multiple systems.

Collaboration & Communication – Serves as a bridge between engineering, quality, and construction teams.

GMP Compliance Focus – Understands the criticality of accurate turnover for regulatory approval and operational readiness.

Full-time