Project Manager/Project Engineer - Pharmaceutical Fill-Finish Facilities

Overview

This position involves leading and managing the complete cycle of engineering projects related to fill-finish manufacturing lines for sterile pharmaceutical products. The professional will oversee planning, designing, procuring, installing, commissioning, qualifying, and handing over advanced fill-finish manufacturing facilities and equipment, ensuring alignment with safety, quality, GMP compliance, regulatory mandates, and business goals.

Key Responsibilities

• Direct the delivery of fill-finish projects from concept through handover, including facility design and integration of process and utilities with equipment specification and procurement.
• Supervise engineering design, construction, and commissioning activities involving filling lines, lyophilizers, isolators/RABS, autoclaves, environmental monitoring, and clean utility systems.
• Lead project scope definition, scheduling, budgeting, resource allocation, and ongoing monitoring/reporting of progress, risks, and performance indicators.
• Conduct sessions to gather user needs, perform risk evaluations such as PHA/HAZOP, and carry out comprehensive design reviews.
• Collaborate closely with internal teams across manufacturing, QA/QC, supply chain, EHS, validation, automation, and maintenance as well as external EPCs, vendors, and consultants.
• Manage procurement processes including quotation requests, bid assessments, vendor selection, and contract administration for critical equipment and project components.
• Review and approve technical documents including design drawings, equipment datasheets, piping and instrumentation diagrams (P&IDs), layouts, and factory/ site acceptance test protocols to ensure compliance with cGMP and regulatory standards.
• Plan and oversee commissioning, qualification, and validation activities for process, utility, and facility systems to confirm readiness and compliance.
• Handle change control management, deviations, and ensure documentation compliance throughout the project life cycle.
• Lead regular project meetings, coordinate cross-functional deliverables, and maintain transparent communication with stakeholders to align objectives.
• Prepare detailed reports for project status, budget tracking, and risk management for internal leadership and governance bodies.
• Guarantee adherence to safety, environmental, and quality standards during all stages of the project.
• Promote continuous improvement initiatives and document lessons learned for future projects.

Minimum Qualifications

• A bachelor's degree or higher in Engineering, Science, or a related technical field is required.
• At least eight years of proven project management or engineering experience in pharmaceutical or biotech sectors, particularly with fill-finish sterile production projects.
• Extensive practical expertise working with fill-finish technologies such as aseptic filling lines, lyophilizers, autoclaves, isolators, restricted airflow barrier systems (RABS), and associated clean utilities.
• In-depth knowledge of current Good Manufacturing Practice (cGMP), FDA/EU regulatory requirements, and industry best practices pertaining to sterile manufacturing operations.
• Demonstrated skill in handling project timelines, budgets, and resource coordination within complex, matrixed organizations.
• Experience delivering design reviews, installation, commissioning, qualification, and technology transfer activities related to fill-finish manufacturing equipment and facilities.