Senior Engineer-35381
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.