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.
#J-18808-Ljbffr
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.
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