Process Engineer

4 weeks ago

Rochester, New York, United States Unither Pharmaceuticals Full time
Job Summary

Serves as a technical resource supporting company objectives with respect to engineering design, process, and implementation of chemical process and controls.

Projects include but are not limited to manufacturing systems, sterile and non-sterile filing systems, process piping, utility systems, new facility construction and upgrades, and other applications.

Key Responsibilities
  • Engage in technical discussions with potential suppliers
  • Organize and write approved specifications based on the needs and requirements
  • Scope projects/work and ensure the solution designed respects the established specifications
  • Execute Projects and Tasks to the approved completion deadlines and within the defined budget
  • Work in partnership with external companies and propose and apply solutions to mitigate and compensate for possible work delays and budget issues
  • Ensure the successful commissioning of the project and manage the installation, commissioning, and validation of equipment
  • Coordinate the various suppliers and vendors and ensure their compliance to health and safety standards and site procedures
  • Possess adequate technical expertise allowing problem resolution and respect the data in the specifications
  • Communicate with affected stakeholders to coordinate activities with respect to their area constraints
  • Assist with commissioning and validation activities required to bring equipment into service and write approved technical reports after commissioning activities
  • Serves in an expert role to assist in writing of qualification protocols, execution of qualification tests, and review and approval of qualification reports
  • Participate in operator training and work with internal customers to define training requirements and provide technical content
  • Organize and/or administer training in collaboration with suppliers and study the technical needs associated with new site investments
  • Participate in different project groups and collect and analyze needs from internal and external stakeholders
  • Define technical solutions and implementations and respect the technical, regulatory, and quality requirements issued by Management and Quality Assurance
  • Consider a wide array of necessary parameters and respect process flows, workshop ergonomics, and safety constraints
  • Ensure the documentation of completed projects is updated and collect technical drawings from vendors for review and ensure they reflect the realized design
  • Create technical drawings of the factory and update according to approved documentation practices
Requirements
  • Bachelor's degree in Chemical Engineering or related discipline with equivalent experience
  • Master's Degree considered a plus
  • Minimum 3 years in either a manufacturing environment, or equipment and packaging technology
  • Experience in a regulated environment (FDA) a plus
  • Experience with solids and liquids manufacturing equipment a benefit
  • Experience with plastic extrusion and molding a benefit
  • Experience with clean room environments and sterile manufacturing preferred
Additional Requirements
  • Demonstrated experience in reading and writing Piping and Instrumentation Diagrams (P&IDs)
  • Ability to specify, procure, oversee installation, commission, and oversee validation of systems and processing equipment
  • Strong background in technical troubleshooting and problem solving
  • Detailed knowledge of equipment operation and validation requirements
  • Ability to work in a matrix organization with cross-functional teams
  • Strong project management skills
  • Proficient knowledge of pharmaceutical cGMP requirements and systems
  • Proficiency in Microsoft Office suite, including non-routine applications like Access, Visio, and Project
  • Proficiency in Computer-Aided Drafting (CAD) software like AutoCAD
Working Conditions

Traditional office environment with frequent visits to other areas of the facility including mechanical areas, production areas, loading docks, and laboratories

Must be able to work on a computer for extended periods of time and must wear safety glasses and other protective items as required

Sitting 75% of the day; standing or walking 25%

Ability to travel for business (Domestic and International)

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