Validation Project Controls and Documentation Specialist

Veg Group; Barceloneta (PR); On-site; USD 85,000 - 110,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a Validation Project Controls and Documentation Specialist to manage validation schedules, master plans, and document workflows across QA and QC programs.

The role emphasizes KPI reporting, schedule governance, and timely delivery of regulatory-ready documentation. You will coordinate with validation engineers, SMEs, and client representatives, track action items, and maintain systems like Kneat, Smartsheet, and MS Project to ensure inspection readiness

Qualifications

• Bachelor’s degree in Engineering, Science, Business, Project Management, or a related discipline.
• Three or more years of pharmaceutical validation documentation, project controls, document control, or scheduling experience.
• Experience with Kneat, CDOCs, Smartsheet, MS Project, or comparable applications.
• Strong organizational, tracking, technical-documentation, and follow-up capabilities.
• Working knowledge of cGMP documentation and validation terminology.

Responsibilities

• Maintain the integrated schedule for periodic monitoring, equipment periodic reviews, computerized-system reviews, audits, and regulatory deliverables.
• Update validation master plans, annual schedules, equipment inventories, action registers, and deliverable trackers.
• Manage document workflows in Kneat, CDOCs, or other approved systems.
• Track document generation, review, comment resolution, data verification, approval, and closure.
• Coordinate document priorities with validation engineers, SMEs, system owners, Quality, and client representatives.
• Monitor schedule adherence, overdue actions, review-cycle duration, and document approval status.
• Prepare monthly KPI and progress reports, including: Schedule adherence, Study success rate, Invalid or failed runs, Human-performance events, Training compliance, Deviation closure, Completed and upcoming deliverables.
• Maintain Smartsheet, MS Project, or equivalent scheduling and reporting tools.
• Support resource-loading forecasts and time-and-material reconciliation.
• Maintain onboarding, training, system-access, and qualification records.
• Schedule governance meetings, prepare agendas, document minutes, and track action items.
• Support inspection-readiness documentation and rapid retrieval of validation records.

Skills

Project coordination

Documentation

Scheduling

Quality compliance

cGMP terminology

Stakeholder communication

Education

Bachelor’s degree in Engineering, Science, Business, Project Management, or related

Tools

Kneat

CDOCs

Smartsheet

MS Project

Job description

Current job opportunities are posted here as they become available.

Validation Project Controls and Documentation Specialist

Validation & Engineering Group, Inc. (V&EG) 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 Validation Project Controls and Documentation Specialist to maintain validation schedules, master plans, document workflows, resource trackers, metrics, and monthly reporting for the QC and QA Validation Maintenance Program.

• Validation Project Controls and Documentation Specialist

Key Responsibilities

• Maintain the integrated schedule for periodic monitoring, equipment periodic reviews, computerized-system reviews, audits, and regulatory deliverables.
• Update validation master plans, annual schedules, equipment inventories, action registers, and deliverable trackers.
• Manage document workflows in Kneat, CDOCs, or other approved systems.
• Track document generation, review, comment resolution, data verification, approval, and closure.
• Coordinate document priorities with validation engineers, SMEs, system owners, Quality, and client representatives.
• Monitor schedule adherence, overdue actions, review-cycle duration, and document approval status.
• Prepare monthly KPI and progress reports, including:
  • Schedule adherence.
  • Study success rate.
  • Invalid or failed runs.
  • Human-performance events.
  • Training compliance.
  • Deviation closure.
  • Completed and upcoming deliverables.
• Maintain Smartsheet, MS Project, or equivalent scheduling and reporting tools.
• Support resource-loading forecasts and time-and-material reconciliation.
• Maintain onboarding, training, system-access, and qualification records.
• Schedule governance meetings, prepare agendas, document minutes, and track action items.
• Support inspection-readiness documentation and rapid retrieval of validation records.

Qualifications

• Bachelor’s degree in Engineering, Science, Business, Project Management, or a related discipline.
• Three or more years of pharmaceutical validation documentation, project controls, document control, or scheduling experience.
• Experience with Kneat, CDOCs, Smartsheet, MS Project, or comparable applications.
• Strong organizational, tracking, technical-documentation, and follow-up capabilities.
• Working knowledge of cGMP documentation and validation terminology.

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.