Engineer

Under general supervision, the Engineer provides technical engineering support to daily manufacturing operations by executing troubleshooting activities, process optimization strategies, and implementing equipment or system modifications. This role applies fundamental engineering principles to resolve operational issues, support capital or process improvement projects, and ensure compliant execution of production activities within a regulated biotech/pharmaceutical environment. The engineer organizes, analyzes, and interprets operational data to recommend solutions for issues of moderate scope and complexity.

This position supports non‑standard shift operations, including extended hours, nights, and weekends as required by business needs.

Key Responsibilities

• Provide solutions to a variety of technical problems of moderate scope and complexity.
• Evaluate, select, and apply standard engineering techniques, principles, and procedures under general supervision.
• Serve as a technical expert for process, equipment, and/or systems during troubleshooting and cross‑functional discussions.
• Actively engage in daily operations when needed to meet production schedules or resolve complex issues.
• Routinely monitor manufacturing processes for performance indicators and operational compliance; recommend corrective actions and provide troubleshooting guidance.
• Apply process, operational, scientific, and basic compliance knowledge to support manufacturing operations.
• Partner with manufacturing, maintenance, process development, utilities, facilities, quality assurance, and validation teams to define requirements and recommendations for process or system modifications.
• Support execution of manufacturing and quality systems including deviations, equipment qualification, process validation, SOP updates, training, and new product introductions.
• Apply basic engineering principles to design and implement system modifications, experiments, and/or capital projects.
• Organize, analyze, and present interpretation of results for operational issues or engineering projects of moderate complexity.
• Work under the direction of project managers to support design, engineering, and construction activities within schedule and budget constraints.
• Collaborate with consultants, architects, and engineering firms in developing standard design documentation.
• Obtain and evaluate vendor quotes for equipment modifications or installations.
• Prepare basic project cost estimates and schedules.

Education Requirements

• Master’s degree in Engineering OR
• Bachelor’s degree in Engineering and 2 years of engineering experience

Preferred Qualifications

• Educational background in Mechanical, Electrical, Industrial, or Chemical Engineering.
• Experience troubleshooting equipment and/or processes in a regulated manufacturing environment.
• Working knowledge of pharmaceutical/biotech processes and GMP production operations.
• Familiarity with validation processes and documentation requirements in highly regulated environments.
• Ability to interpret and apply GLPs, GMPs, and engineering science to production operations.
• Ability to operate specialized laboratory equipment and relevant computer systems.
• Strong analytical and problem‑solving skills.
• Demonstrated skills in:
• Technical report writing
• Technical presentations
• Validation protocol writing
• Managing change
• Equipment‑specific technical troubleshooting
• Personal organization
• Computer literacy
• Excellent verbal communication skills; proficient in English and Spanish.

• Shift: 2/3/2 – 1st Shift (5:00 AM – 5:30 PM) Location: Puerto Rico Department: Manufacturing / Operations Engineering
• 1-year contract with possible extension