Summary: We are seeking an experienced Process Optimization Enginee r to lead the characterization of process optimization strategies and troubleshoot operational issues in operations, manufacturing, pilot plant, or capital project environments.
This role involves applying advanced engineering principles, designing and implementing system modifications, and presenting results for projects of significant scope and complexity.
Responsibilities: Complete complex assignments requiring the development of new or improved engineering techniques.
Develop engineering policies and procedures affecting multiple organizational units.
Supervise, coordinate, and review the work of engineers, associates, and technicians.
Apply advanced engineering principles within and beyond areas of expertise to diverse assignments.
Serve as a technical specialist in engineering methodologies and technologies.
Plan and conduct projects using mature engineering knowledge.
Develop innovative solutions to complex technical problems.
Collaborate with research, manufacturing, process development, quality assurance, and validation teams to define requirements for large system/facility modifications.
Work with project managers to deliver projects within budget, schedule, and quality constraints.
Coordinate efforts with consultants, architects, and engineering firms to develop standard design documents.
Prepare and manage budgets for projects or departmental operations.
Skills and Knowledge: Strong problem-solving and applied engineering expertise.
Proficiency in technical writing and reporting.
Ability to interpret and apply GLPs and GMPs in regulated environments.
Comprehensive understanding of validation protocol execution.
Technical expertise in equipment-specific and analytical problem-solving areas.
Working knowledge of financial analysis tools and project management.
Ability to manage contractors and vendors.
Requirements Education Qualifications: Doctorate degree in Engineering OR Master's degree with 3+ years of engineering experience OR Bachelor's degree with 5+ years of engineering experience.
Preferred Qualifications: Experience with pharmaceutical/biotech production processes, facilities, and equipment.
Familiarity with validation processes, change control, non-conformance management, and CAPAs.
Technical writing experience and proficiency with cGMP procedures.
Experience with Maximo, Purchase Orders (PO), and vendor management.
Ability to manage multiple tasks and priorities simultaneously.
Flexibility to provide after-hours support for 24/7 operations as needed.
Independent, self-motivated, and skilled in collaboration and facilitation.
Shift: 8-hour shifts | 1st Shift Occasional after-hours support may be required to accommodate operational needs.