Senior Process Engineering Specialist

Independently provides and directs the characterization of process optimization strategies and troubleshooting of operational issues within operations, manufacturing, pilot plants, or capital projects environments. Applies advanced engineering principles to the design and implementation of major system modifications, experiments, processes, and capital projects. Develops, organizes, analyzes, and presents interpretations of results for operational issues or engineering projects of significant scope and complexity.

Functions:

• Complete complex or novel assignments requiring the development of new and/or improved engineering techniques and procedures.
• Develop engineering policies and procedures that affect multiple organizational units.
• Supervise, coordinate, and review the work of a small staff of engineers, associates, and/or technicians, both on an ongoing and project basis.
• Employ advanced engineering techniques and/or modifications within your area of engineering expertise.
• Apply knowledge of engineering principles and practices outside of your area of expertise to a variety of assignments in related fields.
• Serve as a peer-recognized engineering technology specialist, with overall responsibility for determining methodologies in specific areas.
• Plan and conduct projects using mature engineering knowledge.
• Develop technical solutions to complex problems, requiring creativity and ingenuity.
• Collaborate with research, manufacturing, process development, utilities, facilities, quality assurance, and validation departments in developing requirements for complex system or facility modifications.
• Work with project managers to complete design and engineering projects within budget, schedule, and quality constraints.
• Coordinate with consultants, architects, and engineering firms on the development of standard design documents.
• Develop departmental or project budgets encompassing multiple disciplines.

EDUCATION REQUIREMENTS:

• Doctorate degree in Engineering, or
• Master’s degree in Engineering with 3 years of related experience, or
• Bachelor’s degree in Engineering with 5 years of related experience.

PREFERRED QUALIFICATIONS:

• Working knowledge of pharmaceutical/biotech processes.
• Familiarity with validation processes.
• Knowledge of GLPs and GMPs and ability to apply them in engineering work.
• Skills in technical report writing, verbal communication, problem-solving, and applied engineering.
• Expertise in process investigations (including deviations, complaints, and CAPA) and inspection technology.
• Knowledge of specialized equipment/process expertise and validation requirements for new equipment installations.

Shift:

• 8-hour shifts, 5 days a week ( 8:00am - 5:00pm)