Project Engineer/ Process Engineer

Project Engineer – Process *Location: Puerto Rico* *Industry: Pharmaceutical / Biopharmaceutical Manufacturing* *Job Summary* We are seeking an experienced *Project Engineer – Process* to provide owner-side engineering and field execution support for a major *Buffer Prep / Buffer Hold (BPBH) brownfield expansion project* within an active 24/7 GMP pharmaceutical manufacturing facility. The Project Engineer will work closely with the Process Lead, General Contractor, A/E engineering firm, site Operations, EHS, and CQV teams to coordinate the installation, commissioning, and turnover of process equipment and process-mechanical systems. This position will focus heavily on *field engineering, contractor coordination, construction oversight, permit-to-work activities, field walkdowns, equipment installation, commissioning support, and GMP compliance*. The successful candidate should be comfortable working in an active pharmaceutical manufacturing environment and coordinating multiple stakeholders. *Key Responsibilities* * Serve as the owner's representative for the process equipment and process-mechanical installation package. * Provide day-to-day field oversight of the General Contractor and subcontractors. * Monitor construction progress, installation quality, safety, and compliance with approved engineering designs and site standards. * Coordinate *Permit-to-Work (PTW)* activities for process construction within an active 24/7 GMP facility. * Coordinate construction segregation, equipment installation activities, tie-ins, and shutdown windows with site Operations. * Conduct and participate in field walkdowns, inspections, punch-list activities, and installation verification. * Coordinate installation of process equipment including *buffer preparation/hold tanks, process skids, heat exchangers, transfer panels/manifolds, CIP/SIP systems, and hygienic process piping*. * Review construction drawings, specifications, P&IDs, process control narratives, contractor submittals, and RFIs. * Coordinate between the General Contractor, A/E engineering team, Process Lead, Operations, EHS, and CQV teams. * Track field issues, open items, punch-list activities, as-built documentation, and project schedule. * Support contractor safety evaluations and ensure compliance with site EHS and GMP requirements. * Support equipment installation, FAT/SAT activities, commissioning, startup, and system turnover. * Assist CQV and Operations teams with field troubleshooting and qualification/commissioning activities. * Maintain accurate field documentation and communicate project status, risks, and issues to the Process Lead. * Ensure construction activities are executed safely without negatively impacting ongoing manufacturing operations. * Work extended hours, weekends, or holidays when required to support critical project activities. *Qualifications* * Bachelor's degree in Chemical, Biomedical, Mechanical Engineering, or a related engineering discipline. * 3–7 years of engineering experience within pharmaceutical, biotechnology, biopharmaceutical, manufacturing, industrial, or capital-project environments. * Experience supporting brownfield construction projects in an operating manufacturing facility. * Experience with contractor coordination, field engineering, construction oversight, or owner's-representative activities. * Familiarity with pharmaceutical/biopharmaceutical process equipment and systems. * Working knowledge of buffer preparation/hold systems, process tanks, process skids, heat exchangers, transfer panels/manifolds, CIP/SIP, and hygienic process piping. * Ability to read and interpret engineering drawings, specifications, P&IDs, and construction documentation. * Experience with commissioning, qualification, validation (CQV), startup, or equipment turnover. * Knowledge of GMP/cGMP requirements and pharmaceutical manufacturing environments. * Experience with Permit-to-Work (PTW), field walkdowns, punch lists, contractor management, and construction safety. * Strong technical writing and documentation skills. * Experience supporting investigations, field issues, deviations, or corrective actions is preferred. * Fluent/bilingual in English and Spanish with excellent verbal communication skills. * Ability to work effectively with contractors, engineering teams, Operations, Quality, EHS, and project leadership. * Willingness to work extended hours, weekends, and holidays when required. Pay: $43.89 - $47.09 per hour Benefits: * Paid time off Work Location: In person