Project Lead Engineer

Overview

In this role you lead engineering projects that support biopharmaceutical manufacturing operations and facility upgrades. You drive scope, schedule, budget, risk, and handover to ensure compliant delivery. You collaborate across QA, Validation, Manufacturing, and other functions to implement process improvements and transfers. You’ll work within GMP/GDP and regulatory frameworks to deliver safe, high-quality outcomes that scale operations. This is a fast-paced, cross-functional role focused on continuous improvement.

Responsibilities

• Lead end-to-end engineering projects with scope, schedule, budget, risk management, reporting and handover
• Provide technical expertise across equipment, utilities, automation, and process systems
• Develop and review URS documentation, engineering designs, drawings, and FAT/SAT protocols
• Coordinate with QA, Validation, Manufacturing, Supply Chain, EHS, contractors, and vendors
• Support design reviews, hazard assessments, commissioning, qualification, and change control activities
• Ensure compliance with GMP/GDP standards and regulatory requirements (FDA, EMA, ICH)
• Manage CAPEX budgets, procurement activities, vendor engagement, and cost tracking
• Identify project risks, maintain project documentation, and drive continuous improvement initiatives

Key requirements

• Strong knowledge of GMP, validation, and pharmaceutical manufacturing environments
• Experience managing multiple engineering projects within regulated industries
• Proficiency with MS Project or Primavera
• Strong analytical, leadership, organisational, and problem-solving skills

• leadership
• analytical thinking
• organizational skills
• GMP knowledge
• validation
• URS and engineering design

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