Tittle: Engineer – PRQN 737

Location: Juncos, Puerto Rico

Work Schedule: Onsite – First and Second Shift

Contract Duration: 6 Months

Positions Available: 1

Schedule Flexibility: Availability to work different shifts, including extended hours, nights, weekends, and holidays, based on business needs.

Important Notice

This opportunity is available only to direct individual candidates. Third-party contractors, staffing vendors, and Corp-to-Corp (C2C) arrangements will not be considered for this position.

Position Summary

Our client is seeking an Engineer to support process characterization, process optimization, troubleshooting, operations, manufacturing, pilot plant activities, and capital projects.

Under general supervision, the Engineer will apply fundamental engineering principles to the design and implementation of system modifications, experiments, and capital projects. The role will also involve organizing, analyzing, and presenting results related to operational issues and engineering projects of moderate scope and complexity.

Key Responsibilities

Engineering & Technical Support

• 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 technical issues involving a limited number of variables and develop appropriate solutions.
• Initiate and complete routine technical assignments and engineering tasks.
• Apply engineering principles and scientific knowledge to support production and operational activities.
• Develop solutions to routine technical problems and support continuous process improvement initiatives.

Operations Engineering

• Serve as a technical resource for equipment and systems, particularly in troubleshooting operational issues.
• Become actively involved in daily operations when needed to meet schedules or resolve complex technical problems.
• Audit the operational performance and regulatory compliance of assigned equipment and systems.
• Collaborate with Research, Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams.
• Support the development of requirements and recommendations for system modifications and improvements.
• Apply engineering principles to production-related technical issues, process characterization, monitoring, and optimization.

Design Engineering & Capital Projects

• Work under the direction of project managers to support design, engineering, and construction projects while meeting schedule and budget requirements.
• Collaborate with consultants, architects, and engineering firms in the development of standard design documentation.
• Obtain and evaluate vendor quotations for equipment modifications and installations.
• Prepare basic project cost estimates and schedules.
• Support capital projects and system modifications from an engineering perspective.

Documentation, Validation & Analysis

• Prepare technical reports and presentations documenting engineering activities, findings, and recommendations.
• Support validation activities and understand validation protocol execution requirements.
• Assist with validation protocol writing and execution.
• Apply statistical analysis and Design of Experiments (DOE) methodologies when appropriate.
• Conduct root cause investigations and support the identification and implementation of appropriate corrective actions.
• Identify and manage Corrective and Preventive Actions (CAPAs).
• Interpret and apply applicable GLP and GMP requirements within a regulated environment.
• Organize, analyze, and present engineering and operational data and results.

Additional responsibilities may be assigned based on business needs.

Education & Experience

• Master’s degree in Engineering, or
• Bachelor’s degree in Engineering with at least 2 years of engineering experience.
• Experience working in a GMP-regulated environment, preferably within the pharmaceutical, medical device, or biotechnology industry.



Preferred Qualifications

• Working knowledge of pharmaceutical or biotechnology processes.
• Familiarity with validation processes and documentation requirements in highly regulated environments.
• Familiarity with packaging equipment, process characterization, validation, monitoring, and optimization techniques.
• Ability to apply engineering principles and scientific knowledge to production environments.
• Experience with technical problem-solving and root cause investigations.
• Experience identifying and managing CAPAs.
• Knowledge of statistical analysis and DOE methodologies.
• Ability to operate specialized laboratory equipment and computer systems, as applicable.
• Strong analytical and problem-solving skills.
• Proficiency in technical report writing.
• Ability to prepare and deliver basic technical presentations.
• Strong organizational and time-management skills.
• Ability to adapt to changing priorities and manage change effectively.
• Strong computer literacy and technical documentation skills.
• Ability to work effectively in a highly regulated, cross-functional environment.
• Effective verbal and written communication skills in both Spanish and English.
• Availability to support non-standard shifts, including extended hours, nights, weekends, and holidays, as required by business needs.