Project Lead

Role & responsibilities:

1. Planning & Design

• Strategic Roadmap: Lead the end-to-end project plan from initial design through commissioning, aligning with business goals.
• Technical Specifications: Oversee detailed engineering (Civil, Structural, MEP) and develop URS and FAT protocols.
• Regulatory Alignment: Ensure all designs meet cGMP and pharmaceutical regulatory standards from the outset.

2. Construction & Execution

• Project Oversight: Manage civil works, structural erection, and MEP/process equipment installation.
• Operational Control: Monitor schedules and budgets, implementing corrective actions to mitigate risks or delays.
• Compliance & Safety: Enforce rigorous quality control and safety standards across all construction activities and vendor management.

3. Commissioning & Qualification (C&Q)

• Validation Lifecycle: Lead C&Q activities, including the preparation and execution of SAT, IQ, OQ, and PQ protocols.
• Process Integrity: Validate critical manufacturing processes and analytical methods to ensure equipment meets performance criteria.
• Documentation: Maintain comprehensive, audit-ready C&Q records compliant with regulatory expectations.

4. Management & Compliance

• Leadership: Direct cross-functional teams (Engineering, QA, Operations) and report status to senior stakeholders.
• Financial & Risk Management: Control project budgets and conduct HAZOP studies and risk assessments to ensure safety and continuity.
• General Governance: Guarantee total adherence to cGMP, environmental, and safety regulations.