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Title: Senior Engineer

Location: Juncos, Puerto Rico

Eligibility: Open to Puerto Rico Residents

Number of Positions: 1

Contract Duration: 5 Months

Work Schedule: On-Site | Administrative Shift (8-hour shifts; overtime may be required based on business needs)

Position Summary

The Senior Engineer independently provides technical leadership in the characterization, optimization, and troubleshooting of manufacturing processes, operational systems, pilot plant activities, and capital projects. This role applies advanced engineering principles and technical expertise to the design, implementation, and execution of process improvements, equipment modifications, validation activities, and engineering projects of significant scope and complexity.

The incumbent develops, organizes, analyzes, and presents technical data and conclusions related to operational challenges, process optimization initiatives, and engineering projects. This position requires strong analytical, problem-solving, project management, and cross-functional collaboration skills within a highly regulated pharmaceutical or biotechnology environment.

Preferred Qualifications

• Experience supporting packaging operations within pharmaceutical or biotechnology manufacturing environments.
• Knowledge of equipment characterization and validation processes.
• Experience with vision systems and inspection system analysis.
• Familiarity with equipment qualification, commissioning, and validation activities.

Essential Responsibilities

General Engineering Responsibilities

• Complete complex and innovative assignments requiring the development and implementation of new or improved engineering techniques and procedures.
• Develop engineering policies, procedures, and technical standards impacting multiple organizational units.
• Provide technical leadership and oversight to engineers, associates, technicians, and project team members.
• Coordinate and review engineering work on both ongoing operational activities and project-based initiatives.
• Apply advanced engineering principles and methodologies to solve complex technical challenges.
• Utilize multidisciplinary engineering knowledge to support a broad range of operational and project-related activities.
• Serve as a recognized subject matter expert in one or more engineering disciplines.
• Plan, execute, and manage engineering projects with minimal supervision.
• Ensure compliance with applicable quality, safety, regulatory, and operational requirements.

Additional duties may be assigned as business needs require.

Design Engineering Responsibilities

• Develop technical solutions for complex engineering challenges requiring creativity, innovation, and sound engineering judgment.
• Collaborate with Manufacturing, Process Development, Research, Utilities, Facilities, Quality Assurance, and Validation teams to define project requirements and engineering solutions.
• Support large-scale facility, equipment, and system modification projects.
• Work closely with project managers to ensure projects are completed within established timelines, budgets, and quality standards.
• Coordinate activities of external consultants, architectural firms, and engineering contractors.
• Review and contribute to the development of engineering design documentation and technical specifications.
• Develop and manage departmental and project budgets involving multiple engineering disciplines.
• Support capital project planning, execution, and implementation activities.

Education and Experience Requirements

Candidates must meet one of the following combinations of education and engineering experience:

• Doctorate Degree; 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.

Required Competencies and Skills

Technical Knowledge

• Working knowledge of pharmaceutical and biotechnology manufacturing processes.
• Strong understanding of equipment qualification, commissioning, and validation processes.
• Familiarity with documentation practices in highly regulated environments.
• Ability to interpret and apply Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
• Knowledge of engineering applications supporting manufacturing and production systems.
• Experience operating specialized laboratory and manufacturing equipment.
• Comprehensive understanding of validation protocol execution requirements.
• In-depth knowledge of validation processes related to new equipment installations and system implementations.
• Specialized expertise in equipment, process technologies, or engineering systems.

Engineering and Problem-Solving Skills

• Strong analytical and technical problem-solving capabilities.
• Ability to apply scientific and engineering principles to identify root causes and develop effective solutions.
• Experience troubleshooting technical issues of moderate to high complexity.
• Ability to independently assess situations and determine when additional internal or external resources are required.
• Skilled in developing solutions for a broad range of engineering and operational challenges.
• Ability to manage multiple projects and priorities simultaneously.

Communication and Documentation

• Effective verbal and written communication skills.
• Technical report writing and documentation expertise.
• Experience preparing and delivering technical presentations.
• Ability to communicate effectively with individuals across various functional areas and organizational levels.
• Strong interpersonal and collaboration skills.

Validation and Compliance

• Experience authoring validation protocols and technical documentation.
• Knowledge of validation lifecycle activities, including equipment qualification and process validation.
• Familiarity with change management and regulated compliance requirements.
• Strong attention to detail and documentation accuracy.

Project Management and Leadership

• Basic to intermediate project management skills.
• Schedule development, planning, and project tracking.
• Ability to delegate responsibilities and manage the work of others.
• Experience leading cross-functional teams and project initiatives.
• Strong organizational and follow-up skills.
• Ability to manage project budgets and support financial analysis activities.
• Experience managing contractors, consultants, and vendors.

Leadership and Business Skills

• Leadership and team-building capabilities.
• Conflict resolution and facilitation skills.
• Negotiation and persuasion abilities.
• Change management and organizational adaptability.
• Effective stakeholder engagement and collaboration.
• Ability to influence technical and business decisions through sound engineering judgment.

Advanced Engineering Competencies

• Demonstrated expertise in at least three engineering technology disciplines.
• Ability to provide solutions to highly complex technical challenges.
• Strong understanding of engineering calculations, scientific methodologies, and technical evaluations.
• Proven ability to lead technical initiatives from concept through implementation.