As the Senior Process Engineer, you will bring relevant experience from pharmaceutical chemical processing or a large scale chemical manufacturing facility to manage, execute, and deliver new capital and non-capital projects, participate in design and safety reviews, interact and collaborate with other disciplines including external contractors, coach and mentor junior engineers, and provide technical leadership within the process engineering team. May be asked to support investigations and correction of process related problems and deviations from standards.
Develops conceptual strategies, processing schemes, feasibility studies, PFD’s, and detailed scopes of work
Develops, reviews, and communicates detailed process design, including P&ID mark-ups, equipment process data sheets, process piping design, and ancillary equipment
Works on several different projects and prioritizes these projects with guidance
Assists in developing control strategy and instrument process design, including emergency and shutdown procedures, instrument specification sheets, control ranges, and alarm points
Designs studies, executes experiments and perform data analysis
Writes study proposals, progress reports, development reports, user requirements, and various technical memos
Evaluates new technologies to improve the commercial production process
Supports scale up activities from R&D to production
Supports buildout of new facilities
Provides required documentation to support compliance
Supports the assurance of a robust manufacturing process for the current registered process as experience is gained post launch
Sets up robust process for trouble shooting
Acts as an effective change agent
Actively participates in the development and mentoring of additional staff
Bachelor’s degree in Chemical Engineering or related discipline, plus a minimum of 5 years of direct chemical processing experience preferably in a pharmaceutical production environment
Experience in process design, project management, and leading a team
Hands-on experience in working with Chemical Operations and preferably API Manufacturing
Experience in reading/writing P&ID’s, Process Flow Diagrams, and mass and energy balances
Experience in batch type operations
Experience with large scale, high volume operations
Demonstrated leadership skills
Understanding of drug product supply chain needs
Experience in the following areas: Process Chemistry scale up; validation activities for commercial production; reactors and drying processes; and, setting up new equipment trains – (URS, PID, DQ, IQ, OQ, PQ)
Desirable for the role:
Capital project experience (CAPEX)
High temperature and high pressure applications
Experience with pressure filter dryer technology
Root cause investigation training
Lean certification
Six-sigma certification
Experience with automatic process controls (PLC, DCS)