Senior Engineer 35570

Title: Senior Engineer (Job ID: 35570)

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

Work Schedule: Onsite | Administrative Shift

Contract Duration: 6 Months

Position Summary

Our client is seeking an experienced Senior Engineer to support engineering initiatives in a highly regulated manufacturing environment. This position is responsible for leading process optimization efforts, troubleshooting complex operational issues, and supporting engineering, packaging, validation, and capital projects.

The ideal candidate will apply advanced engineering principles to design, implement, and improve manufacturing systems while collaborating with cross-functional teams to ensure projects are completed safely, efficiently, and in compliance with quality and regulatory requirements.

Minimum Qualifications

• Bachelor's Degree in Engineering or a related technical discipline.
• Minimum of 4 years of engineering experience in the pharmaceutical or medical device industry.

Education Equivalency

• Doctorate in Engineering, or
• Master's Degree with 2 years of engineering experience, or
• Bachelor's Degree in Engineering with 4 years of engineering experience.

Preferred Qualifications

Candidates with experience in the following areas are highly preferred:

• Pharmaceutical or Medical Device manufacturing environments.
• Packaging equipment and manufacturing systems.
• Design and implementation of new equipment and manufacturing processes.
• Engineering project execution and support.
• Equipment qualification and validation activities.
• Capital improvement projects.
• Process optimization and troubleshooting.
• Technical writing and engineering documentation.
• Excellent communication skills in both English and Spanish.

Key Responsibilities

Engineering & Technical Leadership

• Lead complex engineering assignments requiring innovative engineering solutions.
• Develop and implement process improvements to increase operational efficiency and equipment performance.
• Troubleshoot manufacturing and operational issues using sound engineering principles.
• Analyze engineering data and present technical recommendations to support business decisions.
• Develop engineering procedures and technical documentation that support multiple functional areas.
• Serve as a technical resource and subject matter expert within assigned engineering disciplines.

Project Engineering

• Design and implement engineering solutions for equipment modifications and manufacturing improvements.
• Support engineering studies, experiments, capital projects, and process optimization initiatives.
• Collaborate with Project Managers to ensure projects are completed on schedule, within budget, and in compliance with quality standards.
• Coordinate activities with engineering firms, consultants, architects, contractors, and vendors.
• Assist in the development and management of project budgets.

Cross-Functional Collaboration

Partner with multiple departments including:

• Manufacturing
• Process Development
• Research
• Utilities
• Facilities
• Quality Assurance
• Validation to support equipment installations, facility improvements, and manufacturing initiatives.

Leadership Responsibilities

• Provide technical guidance to engineers, technicians, and engineering associates.
• Coordinate engineering activities across multiple projects.
• Review technical work and engineering deliverables.
• Delegate project tasks while ensuring successful execution.
• Manage contractor and vendor activities when required.

Additional responsibilities may be assigned based on business needs.

Required Technical Knowledge

Candidates should demonstrate knowledge in:

• Pharmaceutical and biotechnology manufacturing processes.
• Medical device manufacturing processes.
• Packaging equipment and systems.
• Validation lifecycle and protocol execution.
• Good Manufacturing Practices (GMP).
• Good Laboratory Practices (GLP).
• Engineering documentation within highly regulated environments.
• Equipment qualification and commissioning.
• Manufacturing process optimization.
• Specialized manufacturing equipment.
• Engineering software and computer applications.

Core Competencies

Engineering Skills

• Advanced engineering problem-solving.
• Process optimization.
• Equipment design and implementation.
• Technical investigations.
• Root cause analysis.
• Engineering calculations.
• Scientific decision-making.

Validation & Compliance

• Validation protocol development and execution.
• Equipment qualification.
• Documentation in regulated manufacturing environments.
• Understanding of GMP and GLP requirements.

Project Management

• Project planning and scheduling.
• Budget development and monitoring.
• Project execution and follow-up.
• Ability to manage multiple projects simultaneously.
• Financial analysis fundamentals.

Leadership & Communication

• Strong leadership and team-building skills.
• Effective collaboration across cross-functional teams.
• Negotiation and conflict resolution.
• Excellent verbal and written communication in English and Spanish.
• Strong organizational and facilitation skills.

Professional Competencies

• Ability to independently identify when additional internal or external resources are needed.
• Ability to solve technical problems ranging from moderate to highly complex.
• Strong analytical thinking and decision-making skills.
• Ability to manage contractors and vendors.
• Ability to influence teams and drive engineering initiatives.