We are seeking a proactive, highly experienced, and detail-oriented Project Engineer to provide critical leadership and technical support . This senior role is responsible for ensuring the successful, compliant, and timely commissioning and qualification (C&Q) of complex process and utility systems, managing project progression, coordinating stakeholders, and driving tasks from design through handover.
Key Responsibilities
- Lead the development, review, and execution of commissioning protocols for complex bioprocess equipment (e.g., bioreactors, purification systems) and critical utility systems (e.g., purified water (PW), water for injection (WFI), clean steam, cleanroom HVAC).
- Mentor and provide technical guidance to the site project and commissioning team and external contractors, acting as a Subject Matter Expert (SME).
- Manage project progression for assigned packages, coordinating with design, procurement, construction, and internal stakeholders to ensure adherence to scope, budget, and schedule.
- Serve as the primary technical point of contact for commissioning and project execution, coordinating directly with Engineering, Validation (CSV/Process), Manufacturing Operations, and Quality Assurance stakeholders.
- Manage the full life-cycle of C&Q documentation, including the review and approval of Design Specifications, Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), and commissioning protocols, ensuring compliance with cGMP and regulatory requirements.
- Witness and sign-off on contractors’ testing and commissioning results, ensuring all activities strictly adhere to approved protocols, industry standards, and internal Quality requirements.
- Proactively conduct site inspections and system punch-listing to identify and resolve complex, project and commissioning-related issues before they impact the subsequent qualification (IQ/OQ/PQ) phases.
- Drive project administration, progress reporting, and documentation handover to the Validation and Operations teams, ensuring a successful transition.
Requirements & Skills
- 3+ years of progressive, relevant experience in project engineering, commissioning, qualification, or validation roles, with a strong focus on biopharmaceutical, pharmaceutical, or regulated advanced manufacturing environments.
- Proven track record of leading or significantly contributing to major capital projects involving cleanroom HVAC, utility systems, and/or complex bioprocess equipment.
- Bachelor’s degree or higher in Mechanical, Electrical, Chemical, Building Services Engineering, or a related discipline.
- In-depth knowledge of cGMP, GEP (Good Engineering Practice), and GAMP (Good Automated Manufacturing Practice) principles.
- Reliable, self-motivated, and a proven team leader with strong ownership and accountability.
- Exceptional communication, negotiation, and stakeholder management skills, comfortable challenging and influencing senior technical and operations personnel.
- Proficient in project management software, Microsoft Office Suite, and relevant data management tools.
