Sr Engineer-Projects and Process Improvements

The Senior Engineer independently leads and directs process optimization initiatives and troubleshooting activities across operations, manufacturing, pilot plant, and capital project environments. This role applies advanced and diverse engineering principles to design and implement major system modifications, experiments, and capital projects. The engineer develops, organizes, analyzes, and presents results for operational issues or engineering projects of significant scope and complexity.

RESPONSIBILITIES

• Complete complex or novel assignments requiring the development of new or improved engineering techniques and procedures.
• Develop engineering policies and procedures that impact multiple organizational units.
• Supervise, coordinate, and review the work of engineers, associates, and technicians on both ongoing and project‑based assignments.
• Apply advanced engineering techniques and modifications within the engineer’s area of expertise.
• Apply engineering principles outside the primary discipline to a broad variety of assignments.
• Serve as a peer‑recognized specialist in at least one engineering technology area, with responsibility for determining methodologies.
• Utilize mature engineering knowledge in planning and executing projects. Additional duties may be assigned.
• Develop technical solutions to complex problems requiring ingenuity and creativity.
• Collaborate with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation to define requirements and recommendations for large or highly complex system or facility modifications.
• Partner with Project Managers to deliver engineering projects within schedule, budget, and quality constraints.
• Coordinate the work of consultants, architects, and engineering firms in developing standard design documents.
• Develop departmental or project budgets involving multiple engineering disciplines.

TECHNICAL SKILLS

• Working knowledge of pharmaceutical/biotech processes.
• Familiarity with validation processes and documentation in highly regulated environments.
• Ability to operate specialized laboratory equipment and computer systems.
• Ability to interpret and apply GLPs and GMPs.
• Specialized equipment and process expertise.
• Technical report writing.
• Validation protocol writing.
• Schedule development and facilitation.
• Basic project management.
• Ability to manage multiple projects simultaneously.
• Working knowledge of financial analysis tools.
• Doctorate OR
• Master’s degree + 2 years of engineering experience OR
• Bachelor’s degree in Engineering + 4 years of engineering experience.

PREFERRED QUALIFICATIONS

• Experience with data analysis, dashboard development, statistical evaluation, GMP documentation, validation principles, and process improvement.
• Working knowledge of automation or AI‑enabled tools such as Python, Codex, Power Automate, SQL, or VBA.
• Experience supporting drug product manufacturing, characterization studies, engineering runs, PPQ, validation deliverables, or manufacturing readiness activities.
• Ability to translate ambiguous operational challenges into practical digital tools, dashboards, or sustainable process improvements.
• Contract: 6 months (administrative shift), with possibility of extension