Senior Project Engineer

Senior Project engineer R&R: • Lead end-to-end project management of engineering capital (CAPEX) projects from concept to handover, ensuring alignment with corporate objectives, regulatory compliance (cGMP, GxP), and site operational needs. • Develop comprehensive project plans, including defining scope, objectives, milestones, timelines, budgets, resource plans, and risk assessments. • Drive feasibility studies, front-end engineering design (FEED), and detailed design in collaboration with internal stakeholders and external consultants to evaluate and shape approved capital projects. • Generate detailed engineering work scopes based on end-user requirements, including cost estimation, procurement strategies, and project execution schedules. • Facilitate and consolidate User Requirement Specifications (URS) by coordinating inputs from multidisciplinary subject matter experts (SMEs) across engineering, production, quality, EHS, and validation teams. • Lead the tendering and procurement process, including preparation of tender documents, technicalbid evaluations, and contract award recommendations for consultants, vendors, and contractors. • Monitor and control project progress, identifying risks, resolving technical and scheduling issues proactively, and ensuring project delivery within approved budget and timelines. • Perform technical review of vendor and contractor submissions, including safety plans, engineering drawings, method statements, and risk assessments for various work types (e.g., confined space, hot work, lifting, working at height, excavation). • Oversee site execution, including construction, equipment installation, site inspections, and system integration, ensuring adherence to design specifications, quality standards, and EHS regulations. • Coordinate commissioning and qualification (C&Q) activities, including IQ/OQ execution and documentation, to ensure systems are compliant and fit for GMP use. • Act as owner’s representative in managing contractors, ensuring compliance with site safety rules, project quality requirements, and regulatory obligations. • Ensure rigorous project documentation management, including change control, site modification requests (SMRs), validation protocols, engineering drawings, meeting minutes, and handover documentation packages. • Collaborate closely with operations, maintenance, quality, validation, and EHS teams to ensure smooth project execution with minimal disruption to manufacturing activities. • Champion continuous improvement and engineering best practices, applying lessons learned and driving efficiency, compliance, and safety enhancements in project delivery. PROJECTS Flexible fume extractor: • Conducted feasibility study and developed concept design for a mobile flexible fume extraction system to safely and effectively capture and control formaldehyde vapors, ensuring compliance with occupational exposure limits and site safety requirements. • Engage potential vendors, performed technical and commercial evaluations, and acquired quotations to identify a fit-for-purpose extraction solution compatible with existing lab/production environments. • Initiated project funding and execution by preparing and submitting a Site Modification Request (SMR) with justifications, technical design brief, cost estimates, and execution strategy for internal approval. • Procured the fume extraction system, coordinating with vendor to ensure delivery meets project lead time, budget, and specification requirements. • Lead and supervise site installation, pre-startup safety review (PSSR), functional testing, and system commissioning, ensuring that the system performance met design intent, safety criteria, and user expectations. • Managecross-functional coordination with EHS, system owner and end users to align installation planning and minimize operational disruption during execution. • Compile the vendor data book, including operating manuals, maintenance procedures, certifications, and commissioning records, and ensured complete handover to end users and document control team for archival • Update as-built drawings reflecting post-installation modifications. • Complete and route SMR closure checklist, ensuring all documentation, validation, sign-offs and operational readiness reviews were completed and approved to formally close the project Stainless steel IBC project: • Lead design, fabrication, and assembly of stainless-steel top covers for Intermediate Bulk Containers (IBCs), ensuring compliance with site specifications, GMP standards, and applicable industry codes for material handling and containment. • Coordinate closely with engineering, production, and safety teams to address design optimization, fitment concerns, and any fabrication or installation challenges during execution. • Conduct feasibility assessment and developed detailed engineering design for modifications to the ethanol dosing system to improve accuracy, reliability, and operational safety, while aligning with process requirements and site safety standards. • Procure and specified instrumentation such as flow meters for ethanol dosing, ensuring compatibility with existing control systems and safety interlocks. • Supervise mechanical fabrication and system modification works, including integration of new components with existing IBCs and piping systems, while maintaining adherence to hygienic design principles and cleanability standards. • Lead on-site installation, PSSR (Pre-Startup Safety Review), functional testing, and commissioning, coordinating with stakeholders to ensure seamless system integration with minimal disruption to production • Ensure strict compliance with safety protocols and environmental regulations throughout fabrication, installation, and commissioning activities, especially in handling flammable ethanol systems • Update engineering drawings and documentation post-installation to reflect as-built conditions and system modif…