Title: Senior Engineer ProQN354

Location: Juncos, Puerto Rico

Eligibility: Open only to local residents of Puerto Rico

Work Arrangement: 100% onsite

Schedule: Administrative shift, with availability to cover overtime or other shifts based on business needs

Positions: 1

Summary

Our client is seeking a Senior Engineer to independently lead and/or direct process characterization, optimization strategies, and troubleshooting of complex operational issues within manufacturing, pilot plant, operations, and capital project environments.

The selected professional will apply advanced engineering principles to the design and implementation of major system modifications, experiments, process improvements, and capital projects. This role will also be responsible for developing, organizing, analyzing, and presenting technical results and recommendations for engineering projects and operational issues of significant scope and complexity.

Preferred Qualifications

• Bachelor’s degree in Engineering with 4+ years of engineering experience preferred.
• Experience with Commissioning & Qualification (C&Q) processes.
• Experience with validation activities and validation protocols.
• Experience with packaging equipment.
• Experience working in pharmaceutical or biotechnology manufacturing environments.

Key Responsibilities

Engineering & Technical Leadership

• Lead complex or novel engineering assignments requiring the development or improvement of engineering techniques, procedures, and methodologies.
• Develop engineering policies and procedures that may impact multiple organizational units.
• Apply advanced engineering principles and techniques to a broad range of technical assignments.
• Serve as a recognized technical resource in at least one area of engineering expertise and establish appropriate methodologies.
• Apply engineering knowledge to plan and execute projects involving complex technical challenges.
• Develop technical solutions to complex problems requiring creativity, engineering judgment, and scientific analysis.
• Identify when additional internal or external resources are required to resolve technical issues.
• Provide solutions for technical problems ranging from routine issues to complex, large-scale challenges.

Manufacturing, Validation & Process Support

• Support manufacturing, process development, utilities, facilities, Quality Assurance, and Validation teams in developing requirements and recommendations for complex system and facility modifications.
• Apply engineering principles and scientific knowledge to manufacturing and production processes.
• Apply knowledge of pharmaceutical/biotechnology processes, GMPs, GLPs, and applicable regulatory requirements.
• Support validation activities, including protocol development and execution for new equipment installations.
• Apply specialized equipment and process expertise to support troubleshooting and optimization activities.
• Interpret technical data, analyze results, and develop engineering recommendations.
• Prepare technical reports, presentations, validation documentation, and other project deliverables.

Project & Design Engineering

• Work with Project Managers to execute engineering and design projects within established schedule, budget, and quality requirements.
• Develop and maintain project schedules, milestones, and follow-up activities.
• Support project cost development, financial analysis, and budget planning.
• Develop project or departmental budgets involving multiple engineering disciplines.
• Coordinate consultants, architects, engineering firms, contractors, and vendors.
• Review and coordinate engineering work and standard design documentation.
• Manage and coordinate multiple projects simultaneously.
• Support project planning, facilitation, collaboration, and execution through project completion.

Leadership & Collaboration

• Supervise, coordinate, and review the work of engineers, associates, and/or technicians on project and ongoing operational assignments.
• Delegate project activities and manage the work of others.
• Provide technical leadership and guidance across multidisciplinary teams.
• Facilitate meetings and collaborate effectively with stakeholders representing different technical and working styles.
• Manage contractors and vendors and support negotiation, coordination, and conflict resolution activities.
• Communicate technical information effectively through written reports, presentations, and verbal discussions.
• Demonstrate strong organization, adaptability, leadership, and team-building skills.

Required Knowledge & Competencies

• Working knowledge of pharmaceutical and/or biotechnology manufacturing processes.
• Knowledge of validation processes, requirements, and documentation practices in highly regulated environments.
• Ability to interpret and apply GMP and GLP requirements.
• Ability to apply engineering science to manufacturing and production processes.
• Strong analytical and applied engineering problem-solving skills.
• Ability to develop technical solutions using scientific and engineering principles, calculations, hypotheses, and structured approaches.
• Ability to independently manage priorities and determine appropriate resources.
• Ability to manage multiple projects and competing priorities.
• Strong technical writing and verbal communication skills.
• Basic project management and facilitation skills.
• Computer literacy and ability to work with specialized laboratory and engineering equipment.
• Experience with validation protocol writing and execution.
• Experience with technical presentations and reporting.
• Knowledge of project cost development and financial analysis tools.
• Demonstrated expertise in at least three areas of engineering technology.
• Strong collaboration, negotiation, persuasion, and conflict-resolution skills.
• Ability to manage contractors, vendors, and project resources.

Additional responsibilities may be assigned based on business needs.