We are seeking an Operational Readiness Senior Associate to drive execution for a world-class biopharmaceutical facility. You will be the central pivot point ensuring all cross-functional milestones- from Factory Acceptance Testing (FAT) through to Process Performance Qualification (PPQ)- are met with precision, safety, and compliance.
Core Responsibilities
- Integrated Execution: Orchestrate a 12-18 month readiness roadmap, aligning Manufacturing, Quality, Engineering, and EHS into a single, seamless execution rhythm.
- Milestone Oversight: Maintain a forward-looking view of critical dependencies (SAT, FT, EMPQ, Media Fills) to ensure equipment and processes are primed for a safe, reliable startup.
- Performance & Governance: Establish structured tracking mechanisms and data-driven dashboards to monitor milestone health. You will identify bottlenecks, drive stakeholder accountability, and escalate risks to leadership.
- Risk Mitigation: Proactively identify schedule conflicts or performance gaps, partnering with functional leads to develop and execute robust mitigation plans.
The Ideal Candidate
You are a highly organized problem-solver who thrives in complex, large-scale project environments and possesses the "AI mindset" necessary to leverage modern data tools for operational excellence.
Requirements
- Education: Level 8 or Bachelor's degree in Science or Engineering.
- Technical Savvy: Proven expertise in building dashboards and data visualizations (MS Office / PM software).
- Lifecycle Knowledge: A solid grasp of biopharma project phases, specifically commissioning and qualification.
- Soft Skills: Exceptional stakeholder management skills with the ability to influence cross-functional teams.
Preferred Experience
Prior experience within a Pharma/Biotech manufacturing or large-scale CAPEX project environment.
Advanced analytical skills and experience managing complex, multi-functional dependencies.
