Position Summary:
The Engineer, Process is responsible for engineering activities related to the development, improvement and optimization of the process and equipment used for the manufacture of terminally sterilized and aseptically filled pharmaceutical products into vials, syringes and IV bag formats.
Job Responsibilities:
- Analyze production and processing problems and initiate project definitions to resolve them
- Design or specify equipment to meet business needs
- Evaluate the feasibility of conceptual projects and prepares detailed analysis, including time and cost for completing the projects
- Assure that assigned projects are in compliance with State, Federal and local codes which encompass environmental protection, FDA requirements, OSHA, and hazardous waste-related issues
- Direct and coordinate activities of various vendors for each project to eliminate any potential conflict and assures that vendors comply with all the safety rules and regulations
- Identify and specify process-specific equipment and performs analysis to justify investments
- Gather data and trend results of overall quality and efficacy of equipment and processes, actively develops process improvements following ROI and cGMP requirements
- Assist in the implementation of new technology as needed to ensure efficiency and quality performance and come up with solutions to improve performance as needed
- Coordinate with related departments and functions to assure appropriate information flow and understanding of overall process improvement direction, assist in the training of personnel as needed
- Develop and maintain process instructions for manufacturing equipment in accordance with site Change Control and Validation requirements
- Perform investigation of manufacturing events
- Perform process & engineering studies
- Collaborate and communicate with other specialists and departmental leaders to coordinate cross-project initiatives and activities
- Maintain personal and equipment logbooks
- Participate in off-site activities at suppliers with reasonable notice
- Plan, execute, and functionally direct engineering projects
- Perform other duties as assigned
Required Skills:
- Must possess good interpersonal skills to establish effective working relationships that are critical in a team environment
- Effective oral and written communication skill set. Requires proficient presentation and technical writing abilities
- Understanding of aseptic processing techniques preferred
- Knowledge of pharmaceutical product development, manufacturing processes, validation, cGMP's and FDA regulations for the Pharmaceutical Industry
- Proficiency in SolidWorks, MS Project, and MS Office products desired
- Process Control and Instrumentation experience a plus
- Project Management experience in food, pharmaceutical or regulated environment preferred
- Must have good analytical skills and be detail-oriented
- Must be able to work as part of a team
- Sterile pharmaceutical product experience strongly preferred
- Experience with critical utilities (WFI, Clean Steam, HVAC etc.) is desired
Education and Experience Requirements:
- ABET accredited Bachelor's degree in an Engineering field is required
- 5 years of team leadership experience (manufacturing / engineering Supervisor/Manager, or U.S. Military rank of E-5 or higher) is required
- 3 years of experience working as a process or project engineer in a manufacturing environment.
- Brownfield/Greenfield experience desired
EOE, including disability/vets.
|
