Sr. Engineer (Biotechnology Industry) - 3000377
Sr. Engineer (Biotechnology Industry) - 3000377
(Open for Puerto Rico Residents)
- Location: Juncos, PR
- Work Arrangement: 100% Onsite, Administrative Shift
- Positions Available: 1
- Duration: Approximately 1 year
Summary
The Sr. Engineer will independently provide and/or direct the characterization of process optimization strategies and troubleshooting of operational issues in manufacturing, pilot plant, or capital projects. This role applies advanced and diverse engineering principles to design and implement major system modifications, experiments, processes, and capital projects. The engineer will develop, organize, analyze, and present interpretations of results for operational issues or projects of significant scope and complexity.
Key Responsibilities
General Responsibilities
- Complete complex or novel assignments requiring the development of new and/or improved engineering techniques and procedures.
- Develop engineering policies and procedures affecting multiple organizational units.
- Supervise, coordinate, and review the work of a small team of engineers, associates, and/or technicians.
- Employ advanced engineering techniques or modifications within the area of expertise.
- Apply engineering principles beyond the area of expertise to a broad variety of assignments.
- Serve as a subject matter expert in at least one engineering area, with responsibility for determining methodologies in that domain.
- Plan and execute projects with mature engineering knowledge.
- Other functions may be assigned as needed.
Design Engineering
- Develop technical solutions to complex problems requiring creativity and ingenuity.
- Work with research, manufacturing, process development, utilities, facilities, quality assurance, and validation teams to develop recommendations for large and complex system modifications.
- Collaborate with project managers to complete design and engineering projects within schedule, budget, and quality constraints.
- Coordinate with consultants, architects, and engineering firms to develop standard design documents.
- Develop departmental or project budgets across multiple disciplines.
Education & Experience Requirements
- Doctorate Degree OR
- Master’s Degree with 3 years of engineering experience OR
- Bachelor’s Degree in Engineering with 5 years of engineering experience.
Preferred Qualifications
- Experience in manufacturing equipment ownership within a CMMS system, including work order approval, PM strategy, spare parts management, and reliability assessments.
- Collaborate with engineering teams to optimize maintenance strategies for manufacturing equipment.
- Enhance system reliability, focusing on equipment availability, downtime reduction, and maintenance optimization.
- Develop performance metrics (availability, downtime) to identify improvement opportunities.
- Lead the implementation of equipment improvement projects.
- Act as a Subject Matter Expert (SME) for systems regarding design, maintenance, and compliance operations.
- Support troubleshooting activities within the functional area.
- Manage deviations and implement CAPAs related to equipment.
- Drive environmental, health, and safety compliance.
Technical Skills & Expertise
- Working knowledge of pharmaceutical/biotech processes.
- Familiarity with validation processes and regulatory documentation.
- Ability to operate specialized laboratory equipment and software.
- Strong understanding of GLPs and GMPs.
- Application of engineering science to production.
- Ability to develop solutions for routine technical problems.
Demonstrated Skills
- Problem-solving and applied engineering.
- Technical report writing and presentations.
- Personal organization and project validation.
- Managing change in technical and regulatory environments.
- Analytical problem-solving and computer literacy.
- Equipment/process expertise and validation protocol execution.
- Effective communication and teamwork with diverse working styles.
- Ability to independently assess resource needs for problem-solving.
- Multitasking across multiple projects with various complexities.
Project & Leadership Skills
- Project scheduling, facilitation, and collaboration.
- Basic project management and task completion.
- Expertise in at least three engineering technologies.
- Ability to manage external resources for complex problem resolution.
- Financial analysis tools for project cost development.
- Delegation and team leadership skills.
- Strong negotiation, persuasion, and facilitation abilities.
- Conflict resolution and team-building expertise.
- Contractor and vendor management experience.
This is an exciting opportunity to contribute to innovative projects in the biotechnology industry. If you meet the qualifications and are looking for a challenging role in a dynamic environment, we encourage you to apply inside the job description!