SENIOR ENGINEER

Location: Onsite – Puerto Rico

Duration: 6 Months

Position Summary

The Senior Engineer provides technical leadership and engineering support for manufacturing operations, process improvements, capital projects, system modifications, and troubleshooting activities within a regulated pharmaceutical or biotechnology environment. This role applies advanced engineering principles to solve complex technical challenges, improve operational performance, and support cross-functional initiatives while ensuring compliance with quality and regulatory requirements.

Key Responsibilities

• Lead and support engineering projects related to manufacturing processes, equipment, facilities, and operational improvements.

• Develop and implement technical solutions for complex process, equipment, and system challenges.

• Perform engineering assessments, root cause investigations, risk evaluations, and corrective action implementation.

• Collaborate with Manufacturing, Quality, Process Development, Validation, Utilities, Facilities, and Maintenance teams to support business objectives.

• Support design, installation, commissioning, qualification, and startup activities for new or modified systems and equipment.

• Manage engineering deliverables to ensure projects are completed within established scope, timelines, budgets, and quality requirements.

• Coordinate activities with contractors, vendors, consultants, and engineering firms as required.

• Prepare and review technical documentation, engineering reports, protocols, specifications, and presentations.

• Support process optimization, continuous improvement, and operational excellence initiatives.

• Participate in project planning, scheduling, budgeting, and execution activities.

Required Qualifications

• Doctorate degree; OR

• Master’s degree with 2+ years of Engineering experience; OR

• Bachelor’s degree in Engineering with 4+ years of Engineering experience.

Preferred Qualifications

• Degree in Chemical Engineering, Mechanical Engineering, Industrial Engineering, Biotechnology, or a related engineering discipline.

• Experience supporting manufacturing, process engineering, production systems, or capital projects within pharmaceutical, biotechnology, medical device, or other highly regulated industries.

• Knowledge of process validation, equipment qualification, commissioning, and startup activities.

• Familiarity with automation systems, manufacturing equipment, and process technologies.

• Experience with continuous improvement methodologies such as Lean Manufacturing, Six Sigma, Kaizen, and Root Cause Analysis.

• Understanding of cGMP regulations, compliance requirements, and Good Documentation Practices (GDP).

Key Competencies

• Strong engineering problem-solving and analytical skills.

• Ability to troubleshoot complex manufacturing and process-related issues.

• Experience leading technical initiatives and supporting cross-functional teams.

• Project management and schedule coordination capabilities.

• Strong technical writing, presentation, and communication skills.

• Ability to manage multiple priorities and projects simultaneously.

• Effective collaboration with operations, quality, validation, maintenance, and engineering teams.

• Experience managing contractors, vendors, and external resources.

• Adaptability, leadership, and sound decision-making skills in a fast-paced environment.

This position requires a hands-on engineering professional capable of independently driving technical solutions, supporting manufacturing operations, and delivering engineering projects in compliance with quality, safety, and regulatory expectations.