We are seeking a skilled Project Engineer with expertise in Facilities, Utilities, and Process Equipment to manage Capital Expenditure (CapEx) projects within a pharmaceutical manufacturing environment. This role is crucial to the successful design, installation, commissioning, and qualification of new facilities, utilities, and process equipment systems, all while ensuring full compliance with Good Manufacturing Practices (GMP) and other regulatory standards (GxP, FDA). The ideal candidate will have a strong background in capital project management and GMP compliance, facilities / utilities, and process equipment within a regulated industry.

Facilities & Utilities Systems Engineering: Oversee the design, procurement, installation, and commissioning of critical utilities systems such as HVAC, purified water, steam, compressed air, clean utilities, and waste systems, ensuring they meet GMP standards. Ensure that all process equipment and utilities infrastructure (cleanrooms, HVAC systems, process piping, etc.) are designed for optimal performance, reliability, and GMP compliance. Manage the integration of utilities and process equipment to ensure seamless operation and compliance with regulatory standards. Capital Project Management: Lead and manage CapEx projects focusing on facilities, utilities, and process equipment systems, ensuring the projects are completed on time, within budget, and in full compliance with GMP regulations. Develop detailed project plans, timelines, and budgets, and ensure resource allocation is adequate to meet project objectives. Collaborate with key stakeholders, including Manufacturing, QA, Regulatory Affairs, and other engineering teams, to define project scope, deliverables, and requirements. Vendor & Contractor Management: Coordinate with external vendors, contractors, and suppliers to ensure that all equipment, systems, and services meet GMP standards and are delivered as per the project schedule. Review contracts, vendor proposals, and technical drawings to ensure they meet specifications and compliance requirements. Process Equipment Design and Implementation: Provide technical guidance for the selection, installation, and commissioning of new process equipment to support pharmaceutical production needs (e.g., reactors, centrifuges, filtration units, mixers, etc.). Review engineering drawings, specifications, and vendor proposals to ensure they align with GMP compliance, operational requirements, and safety standards. Ensure that equipment is capable of meeting operational needs while maintaining compliance with regulatory requirements. GMP and Regulatory Compliance: Ensure all facilities, utilities, and process equipment systems are designed, built, and validated in full compliance with GMP, GxP, and FDA regulations. Collaborate with the CQV, QA, and Regulatory teams to ensure that validation (IQ/OQ/PQ) is conducted appropriately and all systems meet compliance standards before operational use. Review and approve relevant documentation, including project plans, design specifications, and validation protocols, ensuring they meet GMP and regulatory guidelines. Documentation and Reporting: Maintain thorough documentation throughout the project lifecycle, including project plans, risk assessments, validation documents, and change control records. Prepare regular reports and provide updates on project status, milestones, risks, and resource allocation to senior management and stakeholders. Ensure all engineering documentation is compliant with GMP and regulatory standards for internal audits and regulatory inspections. Oversee vendor activities during installation, commissioning, and validation to ensure proper execution and GMP adherence. Continuous Improvement: Identify and implement continuous improvement initiatives related to facilities, utilities, and process equipment systems to enhance operational efficiency, reduce downtime, and improve system performance. Analyze performance data from utilities and process systems to identify opportunities for optimization and cost reductions.