Senior Engineer Proqn958

Title: Senior Engineer – *

Location:
Juncos, PR (Open to Puerto Rico residents only) Work Arrangement: On-site, Administrative Shift Number of Positions: 3 Contract Duration: 6 months SUMMARY Our client is seeking a Senior Engineer to independently lead and support process characterization, optimization strategies, and troubleshooting of operational issues within manufacturing, operations, pilot plant, and capital project environments. The selected candidate will apply advanced engineering principles to the design and implementation of system modifications, process improvements, experiments, and capital projects. Responsibilities include developing, analyzing, and presenting technical assessments and recommendations to address complex operational challenges and engineering initiatives. Preferred Qualifications and Experience Bachelor's degree in Chemical, Mechanical, or Electrical Engineering, with hands-on experience in biopharmaceutical manufacturing. Experience supporting manufacturing equipment and systems in a regulated pharmaceutical or biotechnology environment. Ability to independently conduct technical assessments, manage corrective actions, and lead equipment improvement initiatives. The ideal candidate will have experience in the following areas: Performing System Owner assessments and engineering impact assessments related to equipment failures, process deviations, and quality events. Supporting technical investigations, identifying equipment failure mechanisms, and developing Corrective and Preventive Actions (CAPAs) to minimize recurrence. Evaluating the applicability of CAPAs and lessons learned across other equipment, systems, and manufacturing areas. Managing engineering activities in IBM Maximo , including technical work order reviews, pre-approval and post-approval activities, maintenance coordination, and follow-up through closure. Developing and revising Preventive Maintenance (PM) strategies, Job Plans, inspection requirements, and Standard Operating Procedures (SOPs) . Implementing engineering controls and completing corrective actions associated with safety incidents and INCA records . Supporting equipment troubleshooting, repair coordination, obsolete equipment replacement, spare parts evaluations, and equipment modernization initiatives. Working with biopharmaceutical manufacturing equipment, including centrifuges, autoclaves, process tanks, chromatography and UF/DF systems, homogenizers, filter integrity testers, and associated instrumentation. Preparing technical reports and assessment rationales, maintaining accurate and traceable supporting documentation, and completing assigned actions within established deadlines. Collaborating with Manufacturing, Process Engineering, Maintenance, Quality, Automation, Validation, and equipment suppliers. Managing multiple assignments simultaneously and prioritizing activities based on safety, quality, and operational requirements. FUNCTIONS General Complete complex or novel assignments that require developing new or improved engineering techniques and procedures. Develop engineering policies and procedures that may impact multiple organizational units. Supervise, coordinate, and review the work of a small team of engineers, associates, and/or technicians on an ongoing or project-specific basis. Apply advanced engineering techniques and modify existing methods within the area of engineering expertise. Apply engineering principles and practices beyond the primary area of discipline to a broad range of assignments in related fields. Serve as a recognized engineering technology specialist in at least one area, with responsibility for determining the appropriate methodologies within that specialty. Apply advanced engineering knowledge to project planning and execution. Additional functions may be assigned as needed. Design Engineering Develop technical solutions to complex engineering problems requiring ingenuity, creativity, and independent judgment. Collaborate with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams to establish requirements and recommendations for major or highly complex system and facility modifications. Partner with project managers to deliver design and engineering projects within established schedules, budgets, and quality requirements. Coordinate consultants, architects, and engineering firms in the development of standardized design documentation. Develop departmental or project budgets covering multiple engineering disciplines, either for assigned project areas or smaller projects in their entirety. EDUCATION Candidates must meet one of the following educational and experience

requirements:
Doctorate in Engineering; OR Master's degree in Engineering with at least 2 years of engineering experience; OR Bachelor's degree in Engineering with at least 4 years of engineering experience. COMPETENCIES / SKILLS Candidates should demonstrate the following technical k