Sr Engineer

ECHO Consulting Group•Juncos, PR

About The Position

ECHO Consulting Group is seeking a Senior Engineer to independently characterize process optimization strategies and troubleshoot operational issues in operations, manufacturing, pilot plant, or capital-project environments. The role applies advanced engineering principles to design and implement major system modifications, experiments, processes, and capital projects, and develops, analyzes, and presents results for significant operational issues and engineering projects. The engineer develops solutions to complex engineering problems, establishes engineering policies and procedures affecting multiple organizational units, and may supervise and coordinate the work of a small staff of engineers, associates, or technicians. The position serves as a recognized engineering technology specialist in at least one area and applies mature engineering knowledge across projects and related disciplines. In design engineering, the role develops technical solutions requiring ingenuity and creativity; collaborates with research, manufacturing, process development, utilities, facilities, quality assurance, and validation teams on complex system or facility modifications; and works with project managers to deliver engineering projects within schedule, budget, and quality constraints. The engineer also coordinates consultants, architects, and engineering firms and develops departmental or project budgets. The ideal candidate supports manufacturing equipment and systems in regulated pharmaceutical or biotechnology settings. Work includes technical assessments and impact assessments related to equipment failures, process deviations, and quality events; investigations and corrective and preventive actions; preventive maintenance and SOP development; Maximo work-order management; safety actions; troubleshooting and modernization; and coordination with manufacturing, engineering, maintenance, quality, automation, validation, and equipment suppliers. The role is based in Juncos, Puerto Rico, and is listed as an administrative shift.

Requirements

Doctorate; or a master's degree plus 2 years of engineering experience; or a bachelor's degree in engineering plus 4 years of engineering experience.
Strong knowledge of production and engineering science.
Expertise in writing, executing, and managing validation protocols under strict GLP/GMP standards.
Ability to solve routine to highly complex technical issues using scientific theory, calculations, and data analysis.
Ability to identify and deploy internal or external resources to resolve issues independently.
Experience managing projects from schedule and cost development through execution and completion.
Ability to manage multiple projects and priorities simultaneously.
Skills in supervising third-party contractors and vendors.
Demonstrated delegation, team-building, and collaboration skills across diverse working styles.
Strong negotiation, persuasion, facilitation, and conflict-resolution skills.
Proficiency in technical report writing and professional presentations.

Nice To Haves

Preferred engineering discipline: Chemical, Mechanical, or Electrical Engineering.
Experience supporting manufacturing equipment and systems in a regulated pharmaceutical or biotechnology environment.
Ability to independently manage technical assessments, corrective actions, and equipment improvement initiatives.
Hands-on operation and expertise with laboratory equipment and specialized processes.
Experience with biopharmaceutical manufacturing equipment, including centrifuges, autoclaves, process tanks, chromatography and UF/DF systems, homogenizers, filter integrity testers, and associated instrumentation.

Responsibilities

Complete complex or novel assignments that require developing new or improved engineering techniques and procedures.
Develop engineering policies and procedures that affect multiple organizational units.
Supervise, coordinate, and review the work of a small staff of engineers, associates, and/or technicians on an ongoing and project basis.
Apply advanced engineering techniques or modify advanced techniques within the area of engineering expertise.
Apply engineering principles and practices outside the primary discipline to assignments in related fields.
Serve as a peer-recognized engineering technology specialist in at least one area and determine methodologies for that area.
Plan and conduct projects using mature engineering knowledge.
Develop technical solutions to complex problems requiring ingenuity and creativity.
Collaborate with research, manufacturing, process development, utilities, facilities, quality assurance, and validation departments to develop requirements and recommendations for complex system or facility modifications.
Work with project managers to complete design and engineering projects within schedule, budget, and quality constraints.
Coordinate consultants, architects, and engineering firms in developing standard design documents.
Develop departmental or project budgets encompassing multiple disciplines.
Perform System Owner assessments and engineering impact assessments related to equipment failures, process deviations, and quality events.
Support technical investigations, identify equipment failure mechanisms, and develop corrective and preventive actions to reduce recurrence.
Evaluate whether CAPA and lessons learned apply to other equipment, systems, and manufacturing areas.
Manage engineering activities in IBM Maximo, including work-order technical review, pre-approval and post-approval activities, maintenance coordination, and follow-up through closure.
Develop and revise preventive maintenance strategies, Job Plans, inspection requirements, and SOPs.
Implement engineering controls and complete actions associated with safety incidents and INCA records.
Support equipment troubleshooting, repair coordination, replacement of obsolete equipment, spare-parts evaluations, and equipment modernization projects.
Prepare technical reports and assessment rationales, maintain traceable supporting documentation, and complete actions within established deadlines.
Coordinate with Manufacturing, Process Engineering, Maintenance, Quality, Automation, Validation, and equipment suppliers.
Manage multiple concurrent assignments and prioritize work according to safety, quality, and operational needs.