Title: Senior Engineer | Job ID: 35449
Location: Juncos, Puerto Rico (Open to Puerto Rico Residents)
Work Schedule: Onsite | Administrative Shift
Position Type: 6-Month Contract
Openings: 1
Position Summary
Our client is seeking an experienced Senior Engineer to independently lead and support process optimization initiatives, troubleshoot operational issues, and execute engineering projects within manufacturing, operations, pilot plant, and capital project environments.
This role requires applying advanced engineering principles to design, implement, and optimize complex systems, equipment modifications, experiments, and process improvements. The selected candidate will be responsible for analyzing technical data, interpreting results, and presenting recommendations to support operational excellence in a highly regulated environment.
The ideal candidate will collaborate with multiple business functions and provide technical leadership to engineering teams, technicians, and contractors while ensuring projects are delivered on time, within budget, and in compliance with quality requirements.
Preferred Qualifications
- Bachelor's degree in Mechanical, Electrical, or Industrial Engineering with 4+ years of engineering experience.
- Experience with maintenance, operation, and troubleshooting of automated and manual inspection equipment.
- Knowledge of inspection technologies for parenteral products and glass container systems.
- Experience applying advanced engineering principles to system modifications, process improvements, experiments, and capital projects.
- Ability to improve equipment reliability, efficiency, and overall performance using established engineering methodologies.
- Experience providing technical direction to Mechanics, Automation Technicians, and Information Systems (IS) teams.
- Working knowledge of validation processes and documentation requirements in highly regulated environments.
- Experience developing and executing validation protocols.
- Ability to collaborate with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation departments.
- Strong technical writing, verbal communication, and presentation skills in both English and Spanish.
- Excellent organizational, change management, and problem-solving skills.
Key Responsibilities
General Responsibilities
- Execute complex and innovative assignments that require the development of new or improved engineering techniques and procedures.
- Develop engineering policies and procedures that impact multiple organizational units.
- Supervise, coordinate, and review the work of engineers, technicians, and engineering associates on both ongoing and project-based assignments.
- Apply advanced engineering methodologies within areas of expertise.
- Utilize multidisciplinary engineering knowledge to support a broad range of assignments.
- Serve as a recognized subject matter expert in at least one engineering discipline.
- Plan, execute, and manage engineering projects from initiation through completion.
- Perform additional duties as assigned.
Design Engineering Responsibilities
- Develop technical solutions for complex engineering challenges requiring creativity, innovation, and analytical problem-solving.
- Partner with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams to define requirements for large-scale and highly complex system or facility modifications.
- Collaborate with Project Managers to deliver engineering projects within established schedules, budgets, and quality requirements.
- Coordinate the activities of consultants, architects, and engineering firms during the development of engineering design documents.
- Develop departmental and project budgets that may involve multiple engineering disciplines.
Education Requirements
Candidates must meet one of the following qualifications:
- Doctorate degree in Engineering; OR
- Master's degree in Engineering with 2+ years of relevant engineering experience; OR
- Bachelor's degree in Engineering with 4+ years of relevant engineering experience.
Required Technical Knowledge
- Working knowledge of pharmaceutical and biotechnology manufacturing processes.
- Familiarity with validation processes and validation protocol execution requirements.
- Experience working in highly regulated environments and managing technical documentation.
- Ability to operate specialized laboratory equipment and computerized systems.
- Working knowledge of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
- Ability to apply engineering principles to manufacturing and production environments.
- Capability to develop practical solutions for technical problems of varying complexity.
Required Competencies and Skills
Engineering & Technical Skills
- Applied engineering and analytical problem-solving
- Equipment reliability and performance optimization
- Validation protocol writing and execution
- Technical report writing
- Technical presentations
- Specialized equipment and process expertise
- Equipment installation and commissioning support
- Root cause analysis and troubleshooting
Project Management Skills
- Project planning and schedule development
- Basic project management
- Project cost development and financial analysis
- Project execution and follow-up
- Ability to manage multiple projects simultaneously
- Resource planning and coordination
- Delegation and oversight of project activities
Leadership & Collaboration Skills
- Leadership and team building
- Collaboration across multiple functional areas
- Facilitation and stakeholder management
- Negotiation and persuasion
- Conflict resolution
- Change management
- Contractor and vendor management
Communication Skills
- Technical writing in English and Spanish
- Verbal communication and presentations
- Ability to communicate effectively with diverse teams and stakeholders
- Strong interpersonal and relationship-building skills
Additional Competencies
- Strong organizational skills
- Computer literacy
- Ability to independently identify when additional internal resources are needed to solve problems
- Ability to determine when external resources are required to support project success
- Capability to solve technical problems of moderate to high complexity
- Ability to apply scientific and engineering theories, calculations, and critical thinking to develop effective solutions