Title: Engineer – Job ID 35388

Location: Juncos, Puerto Rico (Open to Puerto Rico Residents)

Positions Available: 2

Work Schedule: 1st and 2nd Shift with availability to support 24/7 non-standard manufacturing operations, including extended hours, nights, and weekends based on business needs.

Contract Duration: 1 Year

Position Summary

Our client is seeking an Engineer to provide technical engineering support for manufacturing operations through process optimization, equipment and process troubleshooting, system modifications, and continuous improvement initiatives.

Working under general supervision, the selected candidate will apply engineering principles to support manufacturing, pilot plant, operational, and capital project environments. This role includes analyzing operational issues, implementing engineering solutions, supporting manufacturing quality systems, and ensuring compliance with corporate policies, industry standards, and applicable regulatory requirements.

Preferred Qualifications

• Bachelor's or Master's degree in Engineering.
• Educational background in Mechanical, Electrical, Industrial, or Chemical Engineering.
• Experience with equipment and/or process troubleshooting in a regulated manufacturing environment.
• Working knowledge of pharmaceutical or biotechnology manufacturing processes.
• Familiarity with validation processes and protocol execution.
• Experience working with documentation in highly regulated environments.
• Knowledge of GMP and GLP requirements.
• Ability to operate specialized laboratory equipment and computer systems.
• Organizational and technical writing skills.
• Strong presentation and communication skills in both English and Spanish.

Key Responsibilities

Engineering Support

• Provide technical engineering support for daily manufacturing operations.
• Develop solutions for technical problems of moderate scope and complexity.
• Evaluate, select, and apply standard engineering techniques, principles, and procedures under general supervision.
• Perform engineering assignments with clearly defined objectives requiring investigation of a limited number of variables.
• Initiate and complete routine technical assignments.

Manufacturing Operations Support

• Serve as a technical resource for process, equipment, and system troubleshooting.
• Actively support manufacturing operations to resolve technical issues and maintain production schedules.
• Monitor manufacturing processes and operational performance indicators.
• Recommend and implement solutions to improve equipment reliability and process performance.
• Provide technical guidance during troubleshooting activities and cross-functional discussions.
• Support manufacturing process optimization strategies.
• Participate in equipment upgrades, replacements, and process modifications.

Cross-Functional Collaboration

• Collaborate with Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams to develop requirements and recommendations for process and system modifications.
• Support cross-functional initiatives to improve manufacturing performance and operational efficiency.

Manufacturing Quality Systems

• Support manufacturing quality systems, including:
• Deviations
• Equipment Qualification
• Process Validation
• Procedures
• Training
• New Product Introductions (NPI)
• Apply engineering, scientific, operational, compliance, analytical, and troubleshooting expertise to support manufacturing operations.
• Ensure all activities are performed in compliance with corporate policies, industry standards, GMP requirements, and applicable regulatory expectations.

Operations Engineering

• Function as a technical expert for assigned equipment and systems during troubleshooting activities.
• Routinely evaluate equipment performance and regulatory compliance for manufacturing systems.
• Support resolution of complex operational issues to maintain production schedules.
• Audit operational performance of equipment and systems with moderate complexity.

Design Engineering

• Support Project Managers in the execution of engineering, design, and construction projects while meeting schedule and budget requirements.
• Collaborate with engineering firms, architects, and consultants in the development of standard design documentation.
• Obtain and evaluate quotations for equipment modifications and installations.
• Prepare preliminary project cost estimates and project schedules.
• Support engineering studies, experiments, system modifications, and capital projects.

Data Analysis & Reporting

• Organize, analyze, and interpret engineering and operational data.
• Present findings and recommendations for operational issues and engineering projects of moderate scope and complexity.
• Prepare technical reports and engineering documentation supporting manufacturing operations.

Minimum Education and Experience

Candidates must meet one of the following qualifications:

• Master's degree in Engineering

OR

• Bachelor's degree in Engineering with 2 years of engineering experience

Required Knowledge and Skills

• Working knowledge of pharmaceutical or biotechnology manufacturing processes.
• Familiarity with validation processes and validation protocol execution.
• Knowledge of GMP and GLP regulations.
• Experience supporting manufacturing operations in regulated environments.
• Equipment and process troubleshooting experience.
• Process optimization and continuous improvement knowledge.
• Engineering problem-solving and analytical skills.
• Technical report and validation protocol writing.
• Technical presentation skills.
• Organizational and project coordination skills.
• Ability to adapt to changing priorities and business needs.
• Computer proficiency.
• Strong verbal and written communication skills in English and Spanish.
• Ability to support non-standard manufacturing schedules, including extended hours, nights, weekends, and 24/7 operations as required.