Job Description:Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.
Requirements & Qualifications:- Experience with data analysis, dashboard development, statistical evaluation, GMP documentation, validation principles, and process improvement.
- Working knowledge of AI-enabled or automation 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 will be a plus.
- Self-driven, comfortable working with ambiguous business needs, and able to translate operational challenges into practical digital tools, dashboards, or sustainable process improvements.
Responsibilities:- Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
- Develop engineering policies and procedures that affect multiple organizational units.
- Coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
- Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
- Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
- Design Engineering:
- Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
- Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.
- Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
- Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
- Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project
Education:- Doctorate OR Masters + 2 years of Engineering experience OR bachelor's in engineering + 4 years of Engineering experience.
