Sr. Engineer 35760

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.

• Direct experience providing technical or process-development support to commercial pharmaceutical, biotechnology, medical-device, or combination-product manufacturing operations.
• Experience managing projects
• Experience with sterile injectable products, prefilled syringes, autoinjectors, pens, or other drug-device combination products.
• Direct knowledge of packaging operations, including primary and secondary packaging, labeling, cartoning, and packaging-line troubleshooting.
• Proven ability to investigate inspection rejects, packaging defects, yield losses, equipment alarms, and process deviations using structured root-cause-analysis tools.
• Experience authoring or reviewing technical protocols, study reports, engineering assessments, investigation reports, risk assessments, work instructions, and change controls.
• Knowledge of process qualification and validation activities, including equipment qualification (IQ/OQ/PQ), process performance qualification, test-method validation, and continued process verification or process monitoring.
• Basic experience using statistical and data-analysis tools to assess process performance, including trend analysis, control charts, process capability, variability assessments, and establishment of monitoring limits.
• Direct experience with GMP-regulated manufacturing and quality-system processes, including deviations, CAPAs, nonconformances, complaints, change controls, and data-integrity requirements.
• Experience collaborating cross-functionally with Manufacturing, Quality Assurance, Quality Control, Engineering, Validation, Maintenance, Automation, Supply Chain, and Regulatory Affairs.
• Experience supporting process improvements, equipment upgrades, new product introductions, technology transfers, or implementation of new inspection and packaging technologies in a commercial environment.
• Ability to provide effective on-the-floor support, communicate clearly with operations personnel, and make timely, data-driven technical decisions while maintaining compliance and product quality.

• →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

• Doctorate OR Masters + 2 years of Engineering experience OR bachelor’s in engineering + 4 years of Engineering experience.