Sr. Engineer 35600

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.

Experience should include:

• Preparation, review, and approval of technical reports, engineering assessments, equipment evaluations, and technical justifications.
• Evaluation of equipment failures, performance issues, maintenance history, operating conditions, and potential impact to product, process, quality, and equipment qualified state.
• Technical support for deviations, investigations, CAPAs, change controls, risk assessments, and post-FDA commitments.
• Assessment of equipment design, functionality, reliability, lifecycle documentation, maintenance strategies, and continued fitness for intended use.
• Review and interpretation of engineering drawings, technical specifications, vendor documentation, equipment manuals, work orders, calibration records, and historical performance data.
• Development of clear, factual, and scientifically justified conclusions and recommendations based on available evidence.
• Experience collaborating with Manufacturing, Maintenance, Automation, Validation, Quality, Process Development, and external vendors to obtain and evaluate technical information.
• Knowledge of cGMP requirements and the ability to ensure that technical assessments are complete, traceable, inspection-ready, and supported by objective evidence.
• Strong technical writing, problem-solving, and communication skills, with the ability to independently manage multiple assessments and deliverables.
• Experience with purification, fermentation, process equipment, utilities, or pharmaceutical manufacturing systems is preferred.
• Strong field presence and willingness to inspect equipment and verify actual operating conditions within manufacturing areas.

• → 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.
• →Supervise, 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.
• →Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
• →Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
• →Application of mature engineering knowledge in planning and conducting projects.
• →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

• Doctorate OR Masters + 2 years of Engineering experience OR Bachelors in Engineering + 4 years of Engineering experience