Tittle: Senior Engineer – ProQN-710

Location: Juncos, Puerto Rico

Work Schedule: On-site | Administrative Shift

Shift Requirements: Must be available to work different shifts and/or weekends based on business needs

Position Available: 1

Contract Duration: 6 months

Important Notice

This opportunity is available exclusively to direct individual candidates. Submissions from third-party contractors, staffing vendors, agencies, or Corp-to-Corp (C2C) arrangements will not be considered.

Position Summary

The Senior Engineer independently provides and/or leads the characterization, optimization, and troubleshooting of complex processes and operational issues within manufacturing, operations, pilot plant, and capital project environments.

This role applies advanced engineering principles to the design and implementation of major system modifications, process improvements, experiments, and capital projects. The Senior Engineer is responsible for developing, organizing, analyzing, and presenting technical results and recommendations for operational challenges and engineering projects of significant scope and complexity.

The successful candidate will work collaboratively across engineering, manufacturing, process development, utilities, facilities, quality assurance, and validation functions while providing technical leadership and practical solutions to complex problems.

Key Responsibilities

General Engineering

• Lead complex or novel assignments requiring the development of new or improved engineering techniques, methods, and procedures.
• Develop engineering policies and procedures that may impact multiple organizational units.
• Supervise, coordinate, and review the work of engineers, associates, and/or technicians on both ongoing and project-based assignments.
• Apply advanced engineering techniques and adapt established methodologies within the applicable engineering discipline.
• Apply engineering knowledge across related technical disciplines to support a broad range of assignments.
• Serve as a recognized technical specialist in at least one area of engineering technology and provide guidance on appropriate methodologies.
• Apply mature engineering judgment to plan, execute, and deliver complex projects.
• Independently identify technical challenges and determine when additional internal or external resources are required.
• Manage multiple projects while maintaining schedule, quality, and business objectives.

Design Engineering & Capital Projects

• Develop technical solutions to complex engineering problems requiring ingenuity, creativity, and sound technical judgment.
• Collaborate with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams to develop requirements and recommendations for major or highly complex system and facility modifications.
• Partner with project managers to execute design and engineering projects within established schedule, budget, and quality requirements.
• Coordinate consultants, architects, engineering firms, contractors, and vendors involved in engineering and design activities.
• Develop standard design documentation and technical deliverables.
• Support the development of departmental and project budgets, including projects involving multiple engineering disciplines.
• Support project cost development, financial analysis, and resource planning.
• Delegate and manage project activities performed by other engineers, contractors, vendors, and technical personnel.

Validation & Regulated Environment

• Apply engineering principles within highly regulated pharmaceutical and biotechnology environments.
• Support validation activities associated with new equipment installations, systems, processes, and facility modifications.
• Demonstrate a comprehensive understanding of validation protocol execution requirements.
• Apply GMP and GLP requirements to engineering and operational activities.
• Prepare and review technical reports, validation documentation, and engineering deliverables.
• Support documentation requirements within a highly regulated environment.
• Apply specialized equipment and process knowledge to engineering and validation activities.

Process Improvement & Technical Analysis

• Characterize processes and develop optimization strategies to improve operational performance.
• Troubleshoot complex manufacturing and operational issues using scientific and engineering principles.
• Analyze technical data and develop practical recommendations based on findings.
• Support process improvement initiatives and engineering studies.
• Develop solutions to technical problems of varying scope and complexity.
• Apply scientific theory, engineering calculations, analytical problem-solving, and creative thinking when developing hypotheses and technical approaches.
• Support data analysis, statistical evaluation, dashboard development, and digital process improvement initiatives.
• Translate operational challenges and ambiguous business needs into practical, sustainable engineering solutions.

Required Education

Candidates must meet one of the following educational and experience requirements:

• Doctorate in Engineering; or
• Master’s degree in Engineering + 2 years of engineering experience; or
• Bachelor’s degree in Engineering + 4 years of engineering experience.

Required Knowledge & Skills

• Working knowledge of pharmaceutical and/or biotechnology manufacturing processes.
• Familiarity with validation processes and requirements.
• Experience working with documentation in a highly regulated environment.
• Ability to operate specialized laboratory and/or engineering equipment and computer systems as appropriate.
• Ability to interpret and apply GMP and GLP requirements.
• Ability to apply engineering principles and scientific knowledge to manufacturing and production environments.
• Strong problem-solving and applied engineering skills.
• Basic technical report-writing skills.
• Strong verbal and written communication skills.
• Ability to prepare and/or support validation protocol documentation.
• Strong organizational and time-management skills.
• Computer literacy and ability to work with technical systems and data.
• Ability to work effectively with individuals with different communication and working styles.
• Ability to manage change and adapt to evolving project requirements.
• Ability to handle multiple projects simultaneously.

Project Leadership & Collaboration

The successful candidate should demonstrate experience in:

• Project planning and schedule development.
• Basic project management.
• Facilitation and cross-functional collaboration.
• Project completion and follow-up.
• Negotiation and persuasion.
• Conflict resolution.
• Leadership and team building.
• Contractor and vendor management.
• Delegation and coordination of project work.
• Developing and managing project costs.
• Determining when internal or external technical resources are needed.
• Providing solutions to technical problems of moderate to large complexity and scope.



Preferred Qualifications

The following experience is preferred and will strengthen a candidate’s profile:

• Data analysis and interpretation.
• Dashboard development.
• Statistical evaluation.
• GMP documentation.
• Validation principles and practices.
• Process characterization and optimization.
• Process improvement methodologies.
• Experience supporting Drug Product manufacturing environments.
• Characterization studies and engineering runs.
• PPQ activities.
• Validation deliverables.
• Manufacturing readiness activities.
• Experience developing digital tools or automated solutions to improve engineering and operational processes.
• Working knowledge of AI-enabled and/or automation tools such as:
• Python
• Codex
• Power Automate
• SQL
• VBA

Ideal Candidate Profile

The ideal candidate is a self-driven and technically capable engineer who can operate effectively in a complex, highly regulated environment.

The candidate should be comfortable working with ambiguous business needs and be able to translate operational challenges into practical engineering solutions, digital tools, dashboards, automation opportunities, or sustainable process improvements.

Strong candidates will combine engineering expertise with analytical problem-solving, project leadership, cross-functional collaboration, and the ability to independently drive complex assignments from concept through completion.

Other duties and responsibilities may be assigned based on business needs.