Senior Engineer-35492

Job Description

Job Description

Title: Senior Engineer (Job ID: 35492)

Location: Juncos, Puerto Rico

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

Work Schedule: Onsite | Administrative Shift - Availability to work different Shifts and/ or weekend or business needs required

Position: 1

Contract Duration: 1 year

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, and capital project environments.

The selected candidate will apply advanced engineering principles to the design and implementation of major system modifications, experiments, processes, and capital projects. This role will develop, organize, analyze, and present technical results and recommendations for operational challenges and engineering projects with significant scope and complexity.

Key Responsibilities

General Engineering

• Complete complex and 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 ongoing and project-based assignments.
• Apply advanced engineering techniques and modify established methodologies within the 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 recognized engineering technology specialist in at least one area, with responsibility for determining appropriate methodologies and approaches.
• Apply mature engineering judgment and technical knowledge when planning and conducting projects.
• Develop technical solutions to complex problems requiring ingenuity, creativity, and sound engineering judgment.
• Independently determine when additional internal or external resources are required to resolve technical issues.
• Provide solutions to a broad range of technical problems with moderate to large complexity and scope.
• Apply scientific and engineering theory, calculations, analytical problem-solving, and creative approaches to develop hypotheses and solutions.

Design Engineering

• Develop technical solutions for complex engineering challenges requiring regular use of ingenuity and creativity.
• Collaborate with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams to develop requirements and recommendations for large-scale or highly complex system and facility modifications.
• Partner with project managers to deliver design and engineering projects within established schedule, budget, and quality requirements.
• Coordinate the activities of consultants, architects, and engineering firms involved in the development of standard design documents.
• Develop departmental or project budgets encompassing multiple engineering disciplines.
• Support project cost development and the evaluation of project financial requirements.
• Coordinate multiple projects while ensuring appropriate completion, follow-up, and communication.

Manufacturing Equipment and Reliability

• Own manufacturing equipment within the CMMS system, including work order approval and closure, preventive maintenance strategy, and spare parts definition, accuracy, and updates.
• Collaborate with Engineering teams to establish and maintain effective maintenance strategies for manufacturing equipment.
• Enhance system reliability by improving equipment availability, reducing downtime, and optimizing maintenance activities.
• Develop and monitor equipment performance metrics, including availability and downtime, to identify opportunities for equipment and process improvement.
• Lead the implementation of manufacturing equipment improvement projects.
• Serve as a Subject Matter Expert (SME) for assigned systems, providing technical expertise related to equipment design, maintenance, and compliance activities.
• Serve as a technical point of contact during compliance-related operations.
• Provide technical support for equipment troubleshooting within the assigned functional area and areas of expertise.
• Support deviation investigations and processes related to manufacturing equipment.
• Define, implement, and maintain ownership of equipment-related CAPAs within the assigned area of expertise.
• Support equipment reliability, maintenance, and change control assessments and requirements.

Quality, Validation, and Compliance

• Apply engineering principles and practices within highly regulated pharmaceutical and biotechnology environments.
• Support validation activities and demonstrate an understanding of validation protocol execution requirements.
• Develop and review validation protocols and related technical documentation.
• Apply knowledge of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
• Apply engineering science and technical principles to manufacturing and production operations.
• Support equipment installations, modifications, and validation activities while ensuring compliance with applicable requirements.
• Maintain appropriate documentation in a highly regulated environment.
• Support deviation and CAPA processes associated with equipment and engineering activities.
• Drive Environmental, Health, and Safety (EHS) compliance within the organization.

Leadership, Collaboration, and Project Management

• Coordinate and manage the project work of engineers, associates, technicians, contractors, vendors, consultants, and other external resources as appropriate.
• Delegate project responsibilities while maintaining accountability for scope, schedule, quality, and deliverables.
• Facilitate cross-functional collaboration and effectively work with individuals with different communication and working styles.
• Demonstrate strong negotiation, persuasion, facilitation, and conflict-resolution skills.
• Build effective working relationships and contribute to team development.
• Manage contractors and vendors supporting engineering and capital projects.
• Develop project schedules and coordinate activities required to achieve project milestones.
• Apply basic project management principles to support successful project execution.
• Manage multiple projects simultaneously and prioritize activities based on business and technical needs.
• Communicate project status, technical findings, and recommendations to appropriate stakeholders.

Education Requirements

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

• 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 and Technical Skills

• Working knowledge of pharmaceutical and/or biotechnology processes.
• Familiarity with validation processes and requirements.
• Comprehensive understanding of validation protocol execution requirements.
• In-depth knowledge of validation processes as they apply to new equipment installations.
• Familiarity with technical documentation requirements in highly regulated environments.
• Ability to interpret and apply GLP and GMP requirements.
• Ability to apply engineering science and principles to manufacturing and production operations.
• Specialized equipment and process expertise.
• Ability to operate specialized laboratory and manufacturing equipment, as applicable.
• Strong computer literacy and ability to use relevant engineering and technical systems.
• Working knowledge of financial analysis tools.
• Ability to develop solutions to routine technical problems within defined scope.
• Strong applied engineering and analytical problem-solving capabilities.
• Ability to prepare basic technical reports and presentations.
• Ability to develop and deliver technical presentations.
• Experience with validation protocol writing.
• Ability to develop and interpret equipment performance metrics.
• Knowledge of equipment reliability, maintenance optimization, and downtime reduction.
• Experience with CMMS systems, work orders, preventive maintenance, and spare parts management.

Core Competencies

• Engineering problem solving
• Analytical thinking
• Applied engineering
• Technical report writing
• Technical presentations
• Validation protocol writing
• GMP and GLP compliance
• Equipment validation
• Equipment troubleshooting
• Change control
• Deviation and CAPA support
• Equipment reliability
• Preventive maintenance strategy
• CMMS systems
• Project management
• Schedule development
• Project cost development
• Financial analysis
• Facilitation
• Collaboration
• Negotiation and persuasion
• Conflict resolution
• Leadership and team building
• Contractor and vendor management
• Communication
• Personal organization
• Adaptability and change management
• Ability to manage multiple projects
• Technical decision-making

Additional Expectations

The successful candidate should be able to:

• Work independently while recognizing when additional technical, organizational, or external resources are needed.
• Manage multiple projects and competing priorities effectively.
• Apply engineering judgment to complex technical challenges.
• Communicate technical information clearly to both technical and non-technical stakeholders.
• Collaborate effectively across Engineering, Manufacturing, Quality, Validation, Facilities, Utilities, Process Development, and other functions.
• Lead equipment improvement and reliability initiatives from planning through implementation.
• Adapt to changing priorities, project requirements, and business needs.
• Demonstrate ownership, accountability, and follow-through on assigned projects and technical responsibilities.



Other functions and responsibilities may be assigned based on business and operational needs.