Project Controller - CQV

Job Roles and Responsibilities

• Develop, maintain, and track CQV project schedules covering Commissioning, IQ, OQ, PQ, CSV, and validation documentation
• Align CQV milestones with pharmaceutical manufacturing readiness and regulatory timelines
• Monitor progress against approved baselines and highlight schedule risks or delays

Cost & Resource Control

• Track CQV project budgets, forecasts, and actuals in regulated pharma projects
• Monitor man-hours, contractor/vendor costs, and change impacts related to CQV scope
• Support cost variance analysis and recovery planning

Progress Tracking & Reporting

• Collect progress data from CQV, Engineering, Automation, and Validation teams
• Prepare weekly and monthly CQV dashboards, KPIs, and management reports
• Track validation documentation status, execution progress, deviations, and punch lists

Change Control & Risk Management

• Support change control processes impacting CQV scope, cost, or schedule
• Track and report CQV-related risks, issues, and mitigation actions
• Maintain controlled records suitable for GMP audits and inspections

GMP Compliance & Documentation

• Ensure project controls follow GMP, GxP, and ALCOA+ principles
• Support inspection readiness by maintaining accurate, traceable CQV records
• Collaborate with Quality Assurance and Validation during internal and regulatory audits

Stakeholder Coordination

• Act as an interface between Project Management, CQV, QA, Engineering, Automation, and Vendors
• Support CQV meetings, MOMs, and action tracking
• Ensure alignment between technical execution and regulatory expectations

Qualifications & Experience

• Bachelor’s degree in Engineering, Life Sciences, or Project Management
• More than 7 years experience in project controls within pharmaceutical or biopharmaceutical projects
• Proven experience supporting CQV / Validation scopes in GMP environments
• Strong understanding of:
  • Commissioning, IQ/OQ/PQ
  • CSV (21 CFR Part 11, EU Annex 11)
  • GMP / GxP regulatory requirements
• Hands-on experience with project planning and reporting tools (MS Project, Primavera, Excel, Power BI)

Key Skills & Competencies

• Pharmaceutical CQV project control
• GMP-compliant planning & reporting
• Cost tracking & forecasting
• Schedule risk identification
• Strong Excel & data analysis skills
• Audit-ready documentation control
• Cross-functional coordination
• High attention to detail

Preferred / Advantageous Experience

• Experience on pharma manufacturing facilities, utilities, labs, or automation projects
• Exposure to FDA, EMA, MHRA inspections
• Experience working with EPCs or CQV service providers
• Knowledge of automation, equipment, utilities, or cleanroom validation