Title: Senior Engineer | Job ID: 35467

Location: Juncos, Puerto Rico (Open to Puerto Rico Residents)

Work Schedule: Onsite | Administrative Shift

Position Type: 1-Year Contract

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 the design, implementation, and optimization of complex systems, equipment modifications, experiments, and process improvements. The selected candidate will be responsible for developing, analyzing, and presenting technical solutions and recommendations for engineering projects of significant scope and complexity.

The ideal candidate will have experience supporting biotechnology and pharmaceutical manufacturing operations, particularly Drug Substance processes, and will collaborate closely with Manufacturing, Process Development, Validation, Quality, Utilities, Facilities, and cross-functional teams to drive operational excellence in a highly regulated environment.

Preferred Qualifications

• Experience supporting biotechnology and pharmaceutical manufacturing processes, with emphasis on Drug Substance operations.
• Working knowledge of GMP pharmaceutical manufacturing systems.
• Experience using SAP, TrackWise, PAS-X Electronic Batch Records (EBR), and Veeva document management systems.
• Strong understanding of process optimization, troubleshooting, and continuous improvement methodologies.
• Ability to support manufacturing operations while ensuring compliance with regulatory and quality requirements.
• Experience collaborating with cross-functional teams in highly regulated environments.

Key Responsibilities

General Responsibilities

• Execute complex and innovative assignments requiring 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, engineering associates, and technicians on both ongoing operations and project-based assignments.
• Apply advanced engineering methodologies within areas of expertise to support manufacturing and operational performance.
• Utilize multidisciplinary engineering knowledge to support a wide variety of assignments and technical challenges.
• Serve as a recognized subject matter expert in at least one engineering discipline and determine appropriate methodologies within that area.
• Apply advanced engineering knowledge in the planning, execution, and completion of projects.
• Perform additional duties as assigned.

Process Optimization & Technical Support

• Characterize and implement process optimization strategies to improve manufacturing performance and operational efficiency.
• Troubleshoot operational issues and develop effective solutions to minimize risk and maximize productivity.
• Analyze technical data and provide recommendations that support data-driven decision-making.
• Identify opportunities for continuous improvement and implement sustainable solutions.
• Support manufacturing operations while ensuring compliance with GMP and quality requirements.

Design Engineering Responsibilities

• Develop technical solutions for complex engineering challenges requiring innovation, creativity, and analytical problem-solving.
• Collaborate with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams to define requirements and recommendations for complex system and facility modifications.
• Partner with Project Managers to complete engineering and design projects within established schedules, budgets, and quality expectations.
• Coordinate activities with consultants, architects, and engineering firms during the development of engineering design documents.
• Support the development and management of departmental and project budgets involving 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 engineering experience; OR
• Bachelor's degree in Engineering with 4+ years of 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 and scientific methodologies to manufacturing and production environments.
• Ability to develop practical and effective solutions for technical challenges of varying complexity.

Required Competencies & Skills

Engineering & Technical Skills

• Process optimization and continuous improvement
• Applied engineering and analytical problem-solving
• Technical troubleshooting
• Equipment and process expertise
• Validation protocol execution
• Validation protocol writing
• Technical report writing
• Technical presentations
• Equipment installation support
• Scientific analysis and data interpretation

Manufacturing Systems & Software

• SAP
• TrackWise
• PAS-X Electronic Batch Records (EBR)
• Veeva Document Management Systems
• Computer literacy and data management systems

Project Management Skills

• Schedule development
• Basic project management
• Project execution and follow-up
• Project cost development
• Financial analysis
• Resource planning and coordination
• Ability to manage multiple projects simultaneously
• 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
• Verbal communication
• Technical presentations
• Effective communication with diverse teams and stakeholders
• Strong interpersonal and relationship-building skills

Additional Competencies

• Strong organizational skills
• Ability to independently determine when additional internal resources are required to resolve issues.
• Ability to identify when external resources are needed to support project success.
• Ability to solve technical problems of moderate to high complexity.
• Strong critical thinking and decision-making skills.
• Ability to apply scientific and engineering theories, calculations, and creativity to develop effective solutions.