Job Description

Job Description

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.

• 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.

• 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).

• 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.

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.

• 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.

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