Title: Engineer 35626

Location: Juncos, Puerto Rico

Eligibility: Open only to Puerto Rico residents

Contract: 6 months

Positions: 1

Shift Availability: Must be available for 5:00 AM and 5:00 PM shifts, including a 2/3/2 schedule with 12-hour shifts.

Example Schedule:

• Week 1: Monday–Tuesday, 12-hour shifts / Friday–Saturday–Sunday, 12-hour shifts
• Week 2: Wednesday–Thursday, 12-hour shifts

Position Summary

Under general supervision, the Engineer will support process optimization, troubleshooting, manufacturing operations, pilot plant activities, and capital projects. The role applies basic engineering principles to system modifications, experiments, and capital projects, while organizing, analyzing,

and presenting results related to operational issues and engineering projects of moderate scope and complexity.

Preferred Educational Background

• Mechanical Engineering
• Electrical Engineering
• Chemical Engineering

Preferred Qualifications & Skills

• Experience troubleshooting equipment and/or processes in a regulated environment.
• Working knowledge of pharmaceutical or biotechnology processes.
• Knowledge of GMP production operations.
• Familiarity with validation processes and validation protocol execution requirements.
• Familiarity with documentation in a highly regulated environment.
• Ability to interpret and apply GLPs and GMPs.
• Ability to apply engineering principles and science to production.
• Ability to develop solutions to routine technical problems of limited scope.
• Ability to operate specialized laboratory equipment and computers, as appropriate.
• Strong problem-solving and applied engineering skills.
• Basic technical report writing and presentation skills.
• Strong verbal communication skills.
• Personal organization and ability to manage change.
• Validation protocol writing skills.
• Technical, equipment-specific knowledge.
• Analytical problem-solving skills.
• Computer literacy.
• Proficiency in English and Spanish.

Key Responsibilities

• Provide solutions to technical problems of moderate scope and complexity.
• Evaluate, select, and apply standard engineering techniques, principles, and procedures under general supervision.
• Perform assignments with clear and specific objectives requiring investigation of a limited number of variables.
• Initiate and complete routine technical tasks.
• Serve as a technical resource for equipment, processes, and systems during troubleshooting activities and multifunctional discussions.
• Become actively involved in daily operations when needed to meet schedules or resolve complex problems.
• Routinely monitor manufacturing processes and equipment for performance indicators and operational compliance.
• Recommend problem resolutions and provide troubleshooting mentorship.
• Work with manufacturing, maintenance, process development, utilities, facilities, quality assurance, and validation teams to develop requirements and recommendations for process and system modifications.
• Support manufacturing and quality systems, including deviations, equipment qualification, process validation, procedures, training, and new product introductions.
• Apply process, operational, scientific, compliance, analytical, and troubleshooting knowledge to support manufacturing operations.
• Organize, analyze, and present results for operational issues and engineering projects.
• Apply basic engineering principles to the design and implementation of system modifications, experiments, and capital projects.
• Routinely audit the operational performance and regulatory compliance of equipment and systems.
• Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance, and validation departments on system modifications.
• Work under the direction of project managers to support design, engineering, and construction projects within schedule and budget constraints.
• Collaborate with consultants, architects, and engineering firms in the development of standard design documents.
• Obtain and evaluate quotes for equipment modifications or installations.
• Develop basic project cost estimates and schedules.
• Support 24/7 non-standard shift operations, including extended hours and weekends, based on business needs.

Required Qualifications

• Master’s degree, OR
• Bachelor’s degree in Engineering with 2 years of Engineering experience.