Engineer - Commercial Engineering Support

We are seeking an Engineer to provide engineering support to commercial operations at a biopharmaceutical manufacturing site in Juncos, Puerto Rico. Under general supervision, this role characterizes process optimization strategies, troubleshoots operational issues and applies engineering principles to system modifications, experiments and capital projects.

Key Responsibilities

• Provide solutions to technical problems of moderate scope and complexity using standard engineering techniques and procedures.
• Act as technical expert for equipment and systems during troubleshooting; support daily operations to meet schedules and resolve complex problems.
• Audit the operational performance and regulatory compliance of equipment and systems.
• Work with Manufacturing, Maintenance, Process Development, Utilities, Facilities, QA and Validation to develop requirements and recommendations for system modifications.
• Support design, engineering and construction projects within schedule and budget; obtain and critique equipment quotes and prepare cost estimates and schedules.
• Organize, analyze and present results for operational issues and engineering projects.

Requirements

• Education
• Master's degree; OR Bachelor's degree in Engineering + 2 years of engineering experience
• Preferred background: Chemical Engineering

Preferred Qualifications

• Statistical analysis experience
• Experience in biotech/pharmaceutical companies
• Drug substance manufacturing or technical support experience
• Familiarity with validation processes and validation protocol execution and writing
• Ability to interpret and apply GMPs and GLPs; documentation in a highly regulated environment
• Key Skills
• Analytical problem solving and applied engineering
• Technical report writing and basic technical presentations
• Personal organization and managing change
• Computer literacy; bilingual English/Spanish communication