Title: Sr. Engineer (Job ID: 3449973)

Location: East Region, Puerto Rico (Open to Puerto Rico Residents)

Work Model: 100% Onsite, Administrative Shift

Openings: 2

Contract Duration: Approximately six (6) months through ProQuality Network

Summary

Our client is seeking highly skilled Senior Engineers to independently provide and/or lead process optimization strategies, troubleshooting of operational issues, and support in operations, manufacturing, pilot plant, or capital projects. This role requires the application of advanced engineering principles to design and implement system modifications, experiments, and large-scale projects. The Senior Engineer will analyze and interpret results, lead technical initiatives, and manage engineering projects of significant complexity.

Preferred Qualifications

• Education/Discipline: Bachelor’s degree or higher in Chemical or Mechanical Engineering.
• GMP Knowledge: Strong background in regulated environments with practical application of GMP in manufacturing and validation.
• Validation Expertise: Experience in drafting, executing, and approving validation documents.
• Technical Knowledge: Hands-on experience with time pressure filling systems.
• Documentation Skills: Skilled in preparing, reviewing, and approving protocols, reports, and technical strategy presentations.
• Protocol Development: Proven ability to design protocols for complex systems, including filling lines and aseptic processes.
• Communication: Strong verbal and written skills in English and Spanish.
• Collaboration: Demonstrated experience working effectively with QA, Manufacturing, and Engineering during critical activities.
• Flexibility: Ability to support non-standard shifts, including nights, weekends, holidays, and extended hours when required.

General Responsibilities

• Complete complex or novel engineering assignments requiring development of new or improved techniques and procedures.
• Develop engineering policies and procedures impacting multiple organizational units.
• Supervise, coordinate, and review work of small teams of engineers, associates, and/or technicians.
• Employ advanced engineering techniques and methodologies within and outside core discipline expertise.
• Serve as a subject matter expert, recognized as a technology specialist in at least one engineering area.
• Apply mature engineering knowledge to the planning and execution of projects.
• Perform other related duties as assigned.

Design Engineering Responsibilities

• Develop technical solutions to complex problems using ingenuity and creativity.
• Collaborate with research, manufacturing, process development, utilities, facilities, quality assurance, and validation teams on system/facility modifications.
• Partner with project managers to deliver engineering projects within scope, budget, and timeline.
• Coordinate with consultants, architects, and engineering firms on the development of standard design documentation.
• Support preparation of departmental and/or project budgets covering multiple engineering disciplines.

Education

• Doctorate in Engineering, OR
• Master’s Degree + 2 years of engineering experience, OR
• Bachelor’s Degree + 4 years of engineering experience.

Technical Knowledge:

• Strong understanding of pharmaceutical/biotech processes.
• Familiarity with validation processes and documentation requirements in regulated environments.
• Ability to operate specialized laboratory equipment and computer systems.
• Strong knowledge of GLPs and GMPs with application to production environments.
• Demonstrated ability to apply engineering science to solve production issues.

Core Skills:

• Problem-solving and applied engineering skills.
• Technical report writing and presentations.
• Personal organization and time management.
• Validation protocol development and execution.
• Change management and adaptability.
• Analytical problem solving and equipment/process expertise.
• Financial analysis and project budgeting.
• Effective collaboration across teams and functions.

Leadership & Project Management:

• Proven skills in project management, scheduling, and follow-up.
• Negotiation, persuasion, and conflict resolution abilities.
• Leadership and team-building across internal staff and contractors/vendors.
• Ability to delegate effectively and manage multiple projects simultaneously.

This is an excellent opportunity for engineering professionals seeking to apply advanced technical expertise in a regulated, high-impact environment. If you are interested in this role, we invite you to apply through the job description link provided.