Sr Engineer

hace 4 semanas

Juncos, Puerto Rico Biopharma Consulting Jad Group A tiempo completo

The Senior Process Engineer independently provides and/or directs the characterization of process optimization strategies and troubleshooting of operational issues within operations, manufacturing, pilot plant, or capital projects environments.
The role involves applying advanced engineering principles to design and implement major system modifications, experiments, processes, and/or capital projects.
The Senior Process Engineer will develop, organize, analyze, and present interpretations of results for operational issues or engineering projects of significant scope and complexity.
Responsibilities: Complete complex or novel assignments requiring the development of new and/or improved engineering techniques and procedures.
Develop engineering policies and procedures that impact multiple organizational units.
Supervise, coordinate, and review the work of a small team of engineers, associates, and/or technicians on an ongoing basis, as well as on a project basis.
Employ advanced engineering techniques and modifications within areas of engineering expertise.
Apply knowledge of engineering principles to a broad variety of assignments in related fields.
Serve as a peer-recognized engineering technology specialist in at least one area, determining methodologies in that area.
Utilize mature engineering knowledge in planning and conducting projects.
Design Engineering Responsibilities: Develop technical solutions to complex problems requiring ingenuity and creativity.
Collaborate with research, manufacturing, process development, utilities, facilities, quality assurance, and validation departments to develop requirements and recommendations for large and/or complex system/facility modifications.
Work with project managers to ensure that design and engineering projects are completed within schedule, budget, and quality constraints.
Coordinate work with consultants, architects, and engineering firms in the development of standard design documents.
Develop departmental or project budgets encompassing multiple disciplines for the area within the project or the entirety of smaller projects.
Key Responsibilities & Attributes: Responsible for managing the equipment lifecycle within the CMMS system.
Perform reliability and change control assessments and collaborate with engineering staff to ensure the best maintenance strategy for manufacturing equipment.
Focus on equipment availability, downtime reduction, and maintenance optimization to improve overall system reliability.
Develop and track equipment performance metrics (availability, downtime, etc.
), focusing on identifying improvement opportunities.
Lead the implementation of equipment improvement projects and serve as the Subject Matter Expert (SME) for systems related to design, maintenance, and compliance operations.
Support troubleshooting efforts within the scope of expertise and oversee deviation processes, implementing CAPAs for equipment within the area of expertise.
Drive compliance with Environmental, Health, and Safety standards across the organization.
Ability to delegate tasks and manage project work effectively.
Strong problem-solving skills, analytical thinking, and technical knowledge.
Ability to manage contractors and vendors.
Ability to collaborate, negotiate, and lead teams effectively.
Requirements Qualifications: Education: Doctorate or Master's degree in Engineering with 3 years of engineering experience, or Bachelor's degree in Engineering with 5 years of engineering experience.
Preferred Qualifications: Working knowledge of pharmaceutical/biotech processes.
Familiarity with validation processes and documentation in highly regulated environments.
Ability to operate specialized laboratory equipment and computers as needed.
Ability to interpret and apply GLPs and GMPs.
Experience with routine technical problem-solving and applied engineering.
Basic skills in technical report writing and verbal communication.
Comprehensive understanding of validation protocol execution requirements.
In-depth knowledge of validation processes and new equipment installations.
Experience in managing multiple projects simultaneously.
Familiarity with financial analysis tools and cost development.

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