Tittle: Senior Engineer – PRQN 760

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: 7 months

Important Notice

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

Position Summary

Our client is seeking a Senior Engineer to independently provide and/or direct process characterization, optimization strategies, and troubleshooting of operational issues within operations, manufacturing, pilot plant, and capital project environments.

The ideal candidate will apply advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, processes, and capital projects. This role will also be responsible for developing, organizing, analyzing, and presenting results related to operational issues and engineering projects of significant scope and complexity.

Key Responsibilities

General Engineering

• Complete 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 modifications within the applicable area of engineering expertise.
• Apply engineering principles and practices outside the primary discipline to a broad range of assignments in related technical fields.
• Serve as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining appropriate methodologies.
• Apply mature engineering knowledge to the planning and execution of complex projects.
• Perform other related functions as assigned.

Design Engineering

• Develop technical solutions to complex problems requiring ingenuity, creativity, and sound engineering judgment.
• Collaborate with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams to develop requirements and recommendations for large-scale and/or highly complex system or facility modifications.
• Partner with project managers to complete design and engineering projects within established schedule, budget, and quality requirements.
• Coordinate the work of consultants, architects, and engineering firms in the development of standard design documentation.
• Develop departmental or project budgets involving multiple engineering disciplines or the overall budget for smaller projects.

Education & Experience

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

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

Core Competencies & Technical Skills

• Working knowledge of pharmaceutical and/or biotechnology processes.
• Familiarity with validation processes and requirements.
• Experience with technical documentation within a highly regulated environment.
• Ability to operate specialized laboratory equipment and computer systems as appropriate.
• Ability to interpret and apply GLP and GMP requirements.
• Ability to apply engineering principles and scientific knowledge to manufacturing and production environments.
• Ability to develop solutions to routine technical problems within a defined scope.
• Strong problem-solving and applied engineering skills.
• Basic technical report-writing skills.
• Effective verbal and written communication skills.
• Comprehensive understanding of validation protocol execution requirements.
• Ability to write and/or review validation protocols.
• Strong organizational and personal planning skills.
• Ability to adapt to and manage change effectively.
• Technical expertise with equipment and process-specific applications.
• Strong analytical problem-solving capabilities.
• Computer literacy and proficiency with applicable technical tools.
• Specialized equipment and/or process expertise.
• In-depth knowledge of validation processes and requirements associated with new equipment installations.
• Ability to interact effectively with individuals with diverse communication and working styles.
• Ability to independently identify when additional internal or external resources are required to resolve technical issues.
• Ability to manage multiple projects simultaneously.
• Ability to develop schedules and facilitate project activities.
• Strong collaboration and follow-up skills.
• Basic project management capabilities.
• Established expertise in at least three separate areas of engineering technology.
• Ability to provide solutions to a broad range of technical problems with moderate to large complexity and scope.
• Strong problem-solving skills involving scientific and engineering theory, calculations, hypothesis development, and creative technical approaches.
• Working knowledge of financial analysis tools.
• Ability to delegate and manage project work performed by others.
• Negotiation, persuasion, and facilitation skills.
• Project cost-development experience.
• Conflict-resolution skills.
• Leadership and team-building capabilities.
• Experience managing contractors and vendors.



Required Industry & Technical Experience

• Direct experience providing technical or process-development support to commercial pharmaceutical, biotechnology, medical-device, or combination-product manufacturing operations.
• Demonstrated project management experience.
• Experience with sterile injectable products, prefilled syringes, autoinjectors, pens, or other drug-device combination products.
• Direct knowledge of packaging operations, including:
• Primary and secondary packaging
• Labeling
• Cartoning
• Packaging-line troubleshooting
• Proven ability to investigate inspection rejects, packaging defects, yield losses, equipment alarms, and process deviations using structured root-cause-analysis methodologies.
• Experience authoring and/or reviewing:
• Technical protocols
• Study reports
• Engineering assessments
• Investigation reports
• Risk assessments
• Work instructions
• Change controls
• Knowledge of process qualification and validation activities, including:
• Equipment qualification (IQ/OQ/PQ)
• Process Performance Qualification (PPQ)
• Test-method validation
• Continued Process Verification (CPV)
• Process monitoring
• Basic experience using statistical and data-analysis tools to evaluate process performance, including:
• Trend analysis
• Control charts
• Process capability
• Variability assessments
• Establishment of monitoring limits
• Direct experience working within GMP-regulated manufacturing and quality systems, including:
• Deviations
• CAPAs
• Nonconformances
• Complaints
• Change controls
• Data-integrity requirements
• Experience collaborating cross-functionally with:
• Manufacturing
• Quality Assurance
• Quality Control
• Engineering
• Validation
• Maintenance
• Automation
• Supply Chain
• Regulatory Affairs
• Experience supporting process improvements, equipment upgrades, new product introductions, technology transfers, or implementation of new inspection and packaging technologies within a commercial manufacturing environment.
• Ability to provide effective on-the-floor technical support, communicate clearly with operations personnel, and make timely, data-driven technical decisions while maintaining compliance and product quality.

What Success Looks Like

The successful candidate will be able to work independently on complex engineering assignments, collaborate effectively across technical and operational functions, and provide practical engineering solutions while maintaining GMP compliance, product quality, project timelines, and business requirements.