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