Senior Engineer ProQN600

Job Description

Job Description

Title: Senior Engineer ProQN600

Location: Juncos, Puerto Rico

Important Notice: This opportunity is available only for direct individual candidates. Third-party contractor submissions, staffing vendors, and Corp-to-Corp (C2C) arrangements will not be considered for this position.

Work Schedule: Onsite | Administrative Shift - Availability to work different Shifts and/ or weekend or business needs required

Position: 1

Contract Duration: 1 year

Position Summary

Our client is seeking a Senior Engineer to independently lead and/or direct process optimization, troubleshooting, engineering assessments, and technical projects within operations, manufacturing, pilot plant, and capital project environments.

The position requires the application of advanced engineering principles to the design and implementation of major system modifications, experiments, process improvements, and capital projects. The Senior Engineer will develop, organize, analyze, and communicate technical results for operational issues and engineering projects involving significant scope and complexity.

Key Responsibilities

General Engineering

• Complete complex or novel engineering assignments that require the development of new or improved engineering techniques, methods, and procedures.
• Develop engineering policies and procedures that may impact multiple organizational units.
• Supervise, coordinate, and review the work of engineers, associates, and/or technicians on ongoing and project-based assignments.
• Apply advanced engineering techniques and modify established approaches within the applicable area of engineering expertise.
• Apply engineering principles and practices outside the primary discipline to a broad range of assignments in related technical fields.
• Serve as a recognized engineering technology specialist in at least one area, with responsibility for determining appropriate methodologies and technical approaches.
• Apply mature engineering knowledge to plan, execute, and manage engineering projects.
• Independently evaluate technical challenges and determine appropriate methodologies, resources, and solutions.

Additional functions may be assigned as needed.

Design Engineering

• Develop technical solutions to complex engineering problems requiring ingenuity, creativity, and sound engineering judgment.
• Collaborate with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams to establish requirements and recommendations for large-scale or highly complex system and facility modifications.
• Partner with project managers to execute design and engineering projects within established schedule, budget, quality, and technical requirements.
• Coordinate consultants, architects, and engineering firms in the development and implementation of standard design documentation.
• Develop departmental or project budgets involving multiple engineering disciplines or the full scope of smaller projects.
• Provide technical input and engineering recommendations throughout project planning, execution, and completion.

Education Requirements

Candidates must meet one of the following educational requirements:

• Doctorate in Engineering or a related technical discipline; or
• Master's degree in Engineering plus at least 2 years of engineering experience ; or
• Bachelor's degree in Engineering plus at least 4 years of engineering experience .

Required Knowledge and Skills

• Working knowledge of pharmaceutical and/or biotechnology manufacturing processes.
• Familiarity with equipment and process validation.
• Experience with technical documentation in highly regulated environments.
• Ability to operate specialized laboratory or manufacturing equipment and use relevant computer systems.
• Ability to interpret and apply GLP and GMP requirements .
• Ability to apply engineering principles and scientific knowledge to manufacturing and production environments.
• Ability to develop solutions to routine technical problems within defined scope.
• Strong problem-solving and applied engineering skills.
• Basic technical report-writing skills.
• Strong verbal and written communication skills.
• Understanding of validation protocol execution requirements.
• Ability to prepare and support validation protocols and related documentation.
• Strong organizational and time-management skills.
• Ability to adapt to changing priorities and manage multiple projects simultaneously.
• Ability to independently identify when additional internal or external resources are required to resolve technical issues.
• Ability to interact effectively with individuals across different communication and working styles.
• Technical expertise with specialized equipment and processes.
• Knowledge of validation requirements associated with new equipment installations.
• Ability to apply analytical and scientific problem-solving techniques to develop hypotheses, evaluate alternatives, and determine appropriate engineering approaches.
• Working knowledge of financial analysis and project cost-development tools.
• Ability to delegate responsibilities and effectively manage the project work of others.

Project Management and Leadership Skills

Demonstrated ability in:

• Schedule development and project coordination.
• Facilitation and cross-functional collaboration.
• Basic project management.
• Project completion, follow-up, and deliverable tracking.
• Negotiation and persuasion.
• Conflict resolution.
• Leadership and team building.
• Project cost development and budget management.
• Managing multiple technical projects and priorities simultaneously.
• Providing solutions to technical problems of moderate to significant complexity and scope.
• Applying engineering theory, scientific principles, calculations, and creative problem-solving techniques to complex technical challenges.
• Establishing engineering expertise in at least three separate areas of engineering technology .

Preferred Experience — Technical Assessments

The preferred candidate will have experience performing technical assessments of equipment in regulated pharmaceutical or biotechnology manufacturing environments .

Experience should include:

• Preparing, reviewing, and approving technical reports, engineering assessments, equipment evaluations, and technical justifications.
• Evaluating equipment failures, performance issues, maintenance history, operating conditions, and potential impacts to products, processes, quality, and the qualified state of equipment.
• Providing technical support for deviations, investigations, CAPAs, change controls, risk assessments, and post-FDA commitments .
• Assessing equipment design, functionality, reliability, lifecycle documentation, maintenance strategies, and continued fitness for intended use.
• Reviewing and interpreting engineering drawings, technical specifications, vendor documentation, equipment manuals, work orders, calibration records, and historical performance data.
• Developing clear, factual, and scientifically supported conclusions and recommendations based on available technical evidence.
• Collaborating with Manufacturing, Maintenance, Automation, Validation, Quality, Process Development, and external vendors to obtain, evaluate, and validate technical information.
• Applying cGMP requirements to ensure technical assessments are complete, traceable, inspection-ready, and supported by objective evidence.
• Preparing clear technical documentation and communicating findings and recommendations to cross-functional stakeholders.
• Independently managing multiple technical assessments, investigations, and deliverables while maintaining established timelines and quality standards.
• Providing technical expertise related to purification, fermentation, process equipment, utilities, and/or pharmaceutical manufacturing systems is preferred.
• Maintaining a strong field presence within manufacturing areas, including inspecting equipment and verifying actual operating conditions.
• Evaluating equipment condition and operating performance using available technical documentation, historical data, maintenance records, and direct field observations.