Senior Engineer – ProQN-630

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

Important Notice: This opportunity is available only to direct individual candidates. Third-party contractor submissions, staffing 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 lead and/or direct process characterization, optimization strategies, and troubleshooting activities 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 also develop, organize, analyze, and present technical results and recommendations related to operational issues and engineering projects of significant scope and complexity.

The position requires strong technical judgment, project leadership, problem-solving skills, and the ability to collaborate effectively with cross-functional teams.

Key Responsibilities:

General Engineering

• Complete complex or novel assignments requiring the development of new or improved engineering techniques, procedures, and solutions.
• 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 existing methodologies 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 recognized engineering technology specialist in at least one area, with responsibility for determining appropriate methodologies and approaches.
• Apply advanced engineering knowledge to plan, execute, and manage projects.
• Perform other related functions as assigned.

Design Engineering

• Develop technical solutions to complex engineering problems using 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 or highly complex system and facility modifications.
• Work with project managers to complete design and engineering projects within established schedule, budget, quality, and technical requirements.
• Coordinate consultants, architects, contractors, and engineering firms involved in developing standard design documentation.
• Develop departmental or project budgets covering multiple engineering disciplines or the full scope of smaller projects.

Commissioning & Qualification (C&Q)

1. C&Q Strategy and Planning

• Develop and implement overall Commissioning & Qualification strategies aligned with project objectives and regulatory requirements.
• Define system boundaries and identify direct- and indirect-impact systems.
• Lead risk assessments, including applicable ISPE Baseline and ASTM E2500 methodologies, to determine qualification scope.
• Develop C&Q plans, schedules, and resource forecasts.

2. Commissioning Activities

• Oversee and/or execute commissioning activities, including Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and field commissioning.
• Verify that systems are installed and operate according to approved design specifications.
• Coordinate with vendors and contractors during equipment startup and commissioning activities.
• Review and approve commissioning documentation, test results, and supporting records.

3. Qualification Execution – IQ/OQ/PQ

• Author, review, and approve qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Ensure traceability from User Requirements Specifications (URS) through qualification testing and final documentation.
• Execute or oversee qualification protocol execution and ensure accurate and complete documentation of results.

4. Documentation and Compliance

• Ensure C&Q documentation meets applicable GMP, FDA, EMA, and internal quality and engineering requirements.
• Maintain documentation throughout the applicable document lifecycle using electronic systems.
• Support data integrity and ALCOA+ principles throughout commissioning and qualification activities.
• Prepare and support validation and qualification summary reports.

5. Risk Management and Change Control

• Lead and document risk assessments associated with system commissioning and qualification.
• Evaluate and manage change controls affecting validated systems.
• Assess the impact of deviations and support the implementation of appropriate corrective and preventive actions (CAPA).

6. Cross-Functional Coordination

• Collaborate with Engineering, Validation, Quality Assurance, Manufacturing, and Supply Chain teams.
• Interface with system owners, technical authorities, and other key stakeholders.
• Provide technical guidance and mentorship to junior engineers and project team members.
• Support project meetings, status reporting, technical discussions, and stakeholder communications.

7. Process Characterization

• Develop process characterization protocols based on project objectives and technical requirements.
• Execute or oversee characterization activities.
• Analyze results and develop technical recommendations based on characterization data.
• Develop and review process characterization reports.
• Present characterization findings and recommendations to relevant stakeholders.

Education

Candidates must meet one of the following educational requirements:

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

Preferred Qualifications and Technical Knowledge

• Working knowledge of pharmaceutical and/or biotechnology manufacturing processes.
• Familiarity with validation processes and qualification 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 practical solutions to technical problems.
• Specialized equipment and process expertise.
• In-depth knowledge of validation processes and requirements related to new equipment installations.

Engineering and Technical Competencies

The successful candidate should demonstrate strong capabilities in:

• Problem-solving and applied engineering.
• Analytical problem-solving and technical decision-making.
• Application of scientific and engineering theory, calculations, and technical analysis.
• Development of hypotheses and creative approaches to complex technical problems.
• Technical report writing and documentation.
• Technical presentations and communication.
• Validation protocol development and execution.
• Computer literacy and technical software applications.
• Technical and equipment-specific knowledge.
• Personal organization and effective time management.
• Managing multiple projects simultaneously.
• Adapting to and effectively managing change.
• Determining when additional internal or external technical resources are required.
• Interacting effectively with individuals with different communication and working styles.

Project Management and Leadership

• Develop project schedules, timelines, and milestones.
• Facilitate technical discussions and project activities.
• Collaborate effectively across functional and technical teams.
• Apply basic project management principles to engineering projects.
• Ensure completion and appropriate follow-up of assigned activities.
• Demonstrate established expertise in at least three distinct areas of engineering technology.
• Provide solutions to a broad range of technical problems with moderate to large complexity and scope.
• Delegate and effectively manage project work performed by others.
• Provide technical leadership, mentorship, and team-building support.
• Manage contractors, consultants, and vendors.
• Support negotiation, persuasion, facilitation, and conflict-resolution activities.
• Develop project costs and support project cost estimates.
• Apply financial analysis tools as appropriate to engineering and capital projects.

Leadership and Collaboration

• Demonstrate strong leadership and team-building capabilities.
• Build productive relationships with internal teams, contractors, vendors, consultants, and other stakeholders.
• Use effective negotiation, persuasion, and facilitation skills to achieve project objectives.
• Resolve conflicts professionally and maintain effective working relationships.
• Independently assess technical challenges and determine the appropriate resources needed to achieve solutions.
• Manage competing priorities while maintaining project quality, schedule, and compliance requirements.