Job Title: Sr. Engineer (3473108)

Location: East Region of Puerto Rico

Work Arrangement: Hybrid/Remote (Onsite Preferred)

Eligibility: Open to Puerto Rico residents who are U.S. citizens

Positions Available: 2

Assignment Duration: Approximately 10 months

Summary

Our client, a leading biotechnology organization, is seeking a Sr. Engineer to provide independent technical leadership in process characterization, optimization strategies, and troubleshooting within manufacturing, operations, pilot plant, or capital project environments. This role applies advanced and diverse engineering principles to the design, implementation, and improvement of complex systems, processes, and capital projects. The Sr. Engineer will also analyze and interpret data, develop recommendations, and present results to support operational excellence and compliance in a highly regulated environment.

Preferred Qualifications

• Hands-on experience in process support, particularly within Drug Substance processes.
• Proficiency in data collection and analysis for process monitoring and performance evaluation.
• Working knowledge of SAP, TrackWise, electronic batch records, and document management systems.

Key Responsibilities

General:

1. Complete complex and novel engineering assignments requiring innovative solutions and advanced technical methodologies.
2. Develop and implement engineering policies and procedures impacting multiple functional areas.
3. Supervise, coordinate, and review the work of engineers, associates, and technicians both continuously and on a project basis.
4. Apply advanced and cross-disciplinary engineering principles to diverse technical challenges.
5. Serve as a recognized subject matter expert in at least one specialized area, establishing methodologies and standards.
6. Plan, conduct, and oversee projects requiring mature engineering judgment and independent decision-making.

Design Engineering:

1. Develop technical solutions to complex problems using creative and analytical engineering approaches.
2. Collaborate with cross-functional teams including Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation.
3. Partner with Project Managers to execute engineering projects within defined timelines, budgets, and quality standards.
4. Coordinate with consultants, architects, and engineering firms to develop standard design documentation.
5. Contribute to or lead the development of departmental or project budgets, ensuring fiscal responsibility and alignment with objectives.

Education Requirements

• Doctorate in Engineering, or
• Master’s degree with a minimum of 2 years of engineering experience, or
• Bachelor’s degree in Engineering with a minimum of 4 years of engineering experience.

Core Competencies and Skills

• Strong working knowledge of pharmaceutical/biotech manufacturing processes.
• Familiarity with validation protocols, GMP, and GLP requirements.
• Proficiency in technical documentation within a regulated environment.
• Strong problem-solving, data analysis, and technical reporting abilities.
• Experience with equipment and process validation, including execution of protocols.
• Excellent communication, collaboration, and organizational skills.
• Demonstrated ability to lead and manage multiple projects simultaneously.
• Competence in project management, budget development, and contractor/vendor oversight.
• Proven capability in leadership, team building, conflict resolution, and cross-functional facilitation.

Invitation to Apply

Qualified professionals who meet the above criteria are encouraged to apply and submit their updated resume inside the job description link for immediate consideration. Join our client’s team and contribute to advancing innovative biotechnological solutions in a dynamic, world-class environment.