We currently have an opportunity for a Sr Project Engineer in our Melrose Park Pharmaceutical Manufacturing facility for providing managerial and technical expertise to direct the efforts of a project team, including process design and development, analysis, recommendation, implementation, cost justification and follow-up on projects designed to increase or improve productivity, capacity, or safety.Responsibilities
- Design and development of complex formulation process including oil in water and oil in water in oil emulsions.
- Provide process engineering support for formulation equipment acquisition from design to the early stages of production.
- Develops process specifications for formulation of conventional small molecule injectable as well as emulsion and complex formulation, including equipment skids, product delivery systems, pressure vessels, pumps, compressors, heat exchangers and all associated equipment.
- Calculate and organize data for process flow diagrams including instrumentation and control considerations.
- Support lab to production scale-up activities in collaboration with multidisciplinary and international teams.
- Design and hand on execution of engineering studies to support new equipment start-up and process improvements.
- Develop P&IDs and 3D Models of process skids and equipment as well as corresponding shop drawings and isometric drawings for field assembly.
- Prepare specifications and process instructions to operate equipment.
- Analyze production and processing problems and initiate project definitions to resolve them.
- Ensure timely and within budget completion of the projects as assigned by his/her manager.
- Evaluate the feasibility of conceptual projects and prepare detailed analysis, including time and cost for completing the projects.
- Maintains awareness of current pharmaceutical manufacturing needs and standards and initiates programs/projects to achieve the goal of facility being a state-of-the-art pharmaceutical manufacturing site.
- Direct and coordinate activities of various vendors for each project to eliminate any potential conflict and assure that vendors comply with all the safety rules and regulations.
- Prepare URS, Risk Assessments, Safety Assessments associated with the project.
- Oversees the execution of the project(s); develop and maintain Process Instructions for manufacturing equipment in accordance with site Change Control and Validation requirements.
- Troubleshoots, amends and accommodates the process of aseptic formulation and fill of drug product
- BS degree in Engineering (Process, Chemical, or Mechanical preferred)
- 5 years manufacturing experience including hands on experience with validated process systems and batch or continuous process system design and implementation.
- Ability to design experiments and analyze resulting data
- Process Control and Instrumentation experience.
- Working knowledge of sanitary connections, valves and pharmaceutical process design.
- Project Management experience preferred.
- Experience with continuous improvement preferred.
- Excellent verbal and written communications skills.
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.