Tittle: Senior Engineer – PRQN 800

Location: Juncos, Puerto Rico

Work Schedule: Onsite – Administrative Shift

Availability: Must be available to work different shifts and/or weekends as business needs require

Contract: 6 months

Positions Available: 2

Important Notice

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

Position Summary

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

The selected candidate will apply advanced engineering principles to the design and implementation of major system modifications, experiments, process improvements, and capital projects. This role requires the ability to develop, organize, analyze, and present technical results related to complex operational issues and engineering projects.

The Senior Engineer will also provide technical leadership, collaborate across multiple functions, and support projects involving significant scope and complexity.

Key Responsibilities

General Engineering

• Complete complex or novel engineering assignments requiring the development of new or improved engineering techniques 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 candidate's area of expertise.
• Apply engineering knowledge and principles across related disciplines and fields.
• Serve as a recognized engineering technology specialist in at least one area, with responsibility for determining appropriate methodologies.
• Apply mature engineering knowledge to the planning and execution of engineering projects.
• Independently identify when additional internal or external resources are required to resolve technical challenges.
• Manage multiple projects while maintaining appropriate follow-up and completion.
• Delegate and manage project work performed by others.

Design Engineering

• 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 large or highly complex system and facility modifications.
• Partner with project managers to complete design and engineering projects within established schedule, budget, and quality requirements.
• Coordinate consultants, architects, and engineering firms in the development of standard design documentation.
• Develop departmental or project budgets involving multiple engineering disciplines.
• Support project cost development and financial analysis activities.
• Provide solutions to a broad range of technical problems involving moderate to large complexity and scope.

Education & Experience

Candidates must meet one of the following:

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

Required Knowledge & Technical Skills

• Working knowledge of pharmaceutical and/or biotechnology processes.
• Familiarity with validation processes and requirements.
• Experience with documentation practices in a highly regulated environment.
• Ability to operate specialized laboratory equipment and computers, as applicable.
• Ability to interpret and apply GLP and GMP requirements.
• Ability to apply engineering principles and scientific knowledge to production environments.
• Understanding of validation protocol execution requirements.
• Knowledge of validation processes and requirements associated with new equipment installations.
• Specialized equipment and/or process expertise.
• Working knowledge of financial analysis tools.

Engineering & Problem-Solving Skills

• Strong problem-solving and applied engineering skills.
• Ability to develop solutions to technical problems of varying complexity.
• Ability to apply scientific and engineering theories, calculations, and creative approaches when developing hypotheses and solutions.
• Ability to independently assess technical issues and determine appropriate approaches.
• Analytical problem-solving skills.
• Ability to manage multiple projects simultaneously.
• Ability to adapt effectively to changing priorities and requirements.

Project & Leadership Skills

• Schedule development and project coordination.
• Basic project management skills.
• Facilitation and collaboration.
• Project cost development.
• Negotiation and persuasion.
• Conflict resolution.
• Leadership and team building.
• Contractor and vendor management.
• Ability to delegate and oversee project activities.
• Ability to determine when additional resources are needed to address technical or project challenges.

Communication & Professional Skills

• Basic technical report writing.
• Technical presentation skills.
• Effective verbal communication.
• Strong organizational and personal management skills.
• Ability to interact effectively with individuals with different communication and working styles.
• Ability to facilitate collaboration across multiple functional areas.
• Strong completion and follow-up skills.



Preferred Qualifications

The following experience would make a candidate stand out:

• Commissioning and Qualification (C&Q) experience involving parenteral products.
• Experience with vision systems.
• Experience with device assembly.
• Experience with packaging systems, including automatic and high-mix/low-volume (HMLV) lines.
• Established expertise in at least three separate areas of engineering technology.

Additional responsibilities and functions may be assigned based on business needs.