Title: Engineer ProQN878

Location: Juncos, Puerto Rico (Open to Puerto Rico residents only)

Positions Available: 1

Contract Duration: 5 months

Schedule Requirements: Weekend support and 12-hour shifts will be required during the implementation phase.

Summary

Under general supervision, the Engineer supports process characterization, optimization strategies, and troubleshooting of operational issues within operations, manufacturing, pilot plant, facilities, or capital projects environments. Applies engineering principles to the design and implementation of system modifications, experiments, and capital projects. Organizes, analyzes, and interprets results related to operational challenges and engineering projects of limited scope and complexity.

The Engineer will collaborate closely with Facilities, Maintenance, Manufacturing, Quality, Validation, Environmental Health and Safety (EHS), and external engineering and service providers to ensure facility systems operate safely, reliably, efficiently, and in compliance with applicable Good Manufacturing Practices (GMP) and regulatory requirements.

Preferred Qualifications

• Experience providing engineering support for the operation, troubleshooting, optimization, and modification of HVAC, utilities, and facility systems within a regulated pharmaceutical or biotechnology environment.
• Knowledge of pharmaceutical and biotechnology processes, validation practices, and documentation requirements in highly regulated environments.
• Ability to interpret and apply Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
• Ability to apply engineering principles to production operations and resolve routine technical problems of limited scope.
• Experience supporting preventive maintenance strategies, facility modifications, and capital projects.
• Understanding of validation protocol execution requirements and validation documentation.
• Skills in problem-solving, applied engineering, and analytical troubleshooting.
• Ability to prepare basic technical reports and presentations.
• Strong verbal communication and technical writing skills.
• Effective personal organization and time management.
• Ability to adapt to changing priorities and manage change effectively.
• Computer literacy and familiarity with specialized equipment and relevant software.
• Ability to work collaboratively with cross-functional teams and external service providers.

Education and Experience

• Master's degree in Engineering; or
• Bachelor's degree in Engineering and at least two (2) years of engineering experience.

Responsibilities

General Engineering Functions

• Provide technical solutions to engineering and operational problems of moderate scope and complexity.
• Evaluate, select, and apply standard engineering techniques and procedures under general supervision, seeking assistance for unusual or complex problems as needed.
• Execute assignments with defined objectives that require investigating a limited number of variables.
• Initiate and complete routine technical tasks in accordance with established requirements and schedules.

Operations Engineering

• Serve as a technical resource for assigned equipment and systems, troubleshooting operational issues and supporting daily operations as needed to meet schedules and resolve complex problems.
• Conduct routine assessments of equipment and system performance to evaluate operational effectiveness and regulatory compliance.
• Collaborate with Research, Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams to develop requirements and recommendations for system modifications.
• Support the optimization, reliability, and efficient operation of facility systems within a regulated environment.
• Assist with troubleshooting and the implementation of corrective solutions to address equipment and system performance issues.

Design Engineering and Project Support

• Work under the direct supervision of project managers to support design, engineering, and construction projects while meeting established schedules and budget requirements.
• Collaborate with consultants, architects, and engineering firms to develop standard design documents.
• Obtain and evaluate quotations for equipment modifications and installations.
• Prepare preliminary project cost estimates and schedules.
• Support facility modifications and capital projects in coordination with relevant stakeholders.

Additional responsibilities may be assigned as needed.