Title: Engineer 35631 – Biotechnology Industry

Location: Juncos, Puerto Rico (Only for Puerto Rico residents)

Position: 1 Opening

Schedule: Administrative Shift - Availability to work different Shifts and/ or weekend as business needs required

Contract: 6 months

Position Summary

Our client is seeking an Engineer to support process optimization, operational troubleshooting, engineering projects, and system modifications within a biotechnology manufacturing environment.

Under general supervision, the Engineer will characterize process optimization strategies and troubleshoot operational issues across manufacturing, operations, pilot plant, and capital project environments. The role applies fundamental engineering principles to the design and implementation of system modifications, experiments, and capital projects.

The Engineer will also organize, analyze, and present results related to operational issues and engineering projects of limited to moderate scope and complexity.

Key Responsibilities

General Engineering

• Provide solutions to a variety of technical problems of moderate scope and complexity.
• Evaluate, select, and apply standard engineering techniques and procedures under general supervision.
• Investigate assignments involving a limited number of variables and clearly defined objectives.
• Initiate and complete routine technical assignments and engineering tasks.
• Apply engineering principles and scientific knowledge to support manufacturing and production activities.
• Develop solutions to routine technical problems within established guidelines.

Operations Engineering

• Serve as a technical resource for equipment and systems, supporting operational troubleshooting and issue resolution.
• Become actively involved in daily operations when necessary to meet production schedules or resolve complex technical issues.
• Routinely audit the operational performance and regulatory compliance of equipment and systems of moderate complexity.
• Collaborate with Research, Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams to develop requirements and recommendations for system modifications.
• Support troubleshooting activities and recommend appropriate technical solutions to improve equipment and system performance.
• Assist with engineering activities associated with manufacturing and biotechnology operations.

Design Engineering and Capital Projects

• Work under the direction of project managers to support design, engineering, and construction projects while meeting established schedule and budget requirements.
• Collaborate with consultants, architects, and engineering firms in the development of standard design documentation.
• Obtain, review, and provide technical input on quotes for equipment modifications and installations.
• Prepare basic project cost estimates and schedules.
• Support system modifications, engineering studies, experiments, and capital projects as assigned.
• Assist with project documentation and technical deliverables throughout the project lifecycle.

Documentation, Validation, and Compliance

• Support the preparation and execution of validation protocols in accordance with established requirements.
• Prepare basic technical reports, presentations, and engineering documentation.
• Apply Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) as applicable.
• Maintain appropriate documentation within a highly regulated biotechnology environment.
• Support activities related to regulatory compliance, equipment qualification, and validation.
• Interpret technical information and communicate findings and recommendations to appropriate stakeholders.

Required Qualifications

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

Preferred Qualifications

• Working knowledge of pharmaceutical or biotechnology manufacturing processes.
• Experience or familiarity with biotechnology processes, particularly purification operations.
• Knowledge of chromatography and ultrafiltration/diafiltration (UF/DF or UFDF) techniques.
• Familiarity with validation processes and validation protocol execution requirements.
• Experience working with documentation in a highly regulated environment.
• Ability to interpret and apply GLP and GMP requirements.
• Ability to apply engineering principles and scientific knowledge to production and manufacturing operations.
• Ability to operate specialized laboratory equipment and computer systems as required.
• Strong problem-solving and applied engineering skills.
• Basic technical report writing and presentation skills.
• Familiarity with validation protocol writing.
• Strong analytical problem-solving abilities.
• Effective verbal communication skills.
• Strong personal organization and time-management skills.
• Computer literacy and ability to work with applicable technical systems.
• Ability to adapt to changing priorities and effectively manage change.
• Ability to develop practical solutions to routine technical problems of limited scope.
• Technical knowledge related to equipment and systems used in biotechnology manufacturing.



Core Competencies

• Engineering Problem Solving
• Process Optimization
• Operations Engineering
• Equipment Troubleshooting
• Biotechnology Manufacturing
• Purification Operations
• Chromatography
• UFDF/UF/DF
• GMP/GLP Compliance
• Validation
• Validation Protocol Execution
• Technical Documentation
• Capital Projects
• Equipment Modifications
• Analytical Problem Solving
• Technical Reporting and Presentations
• Cross-Functional Collaboration
• Change Management
• Computer Literacy

Additional responsibilities may be assigned based on business and operational needs.