Process Engineer

Responsibilities

• Lead for lab and pilot scale development testing of evaporation and drying technology.
• Responsible for design of experiments, benchtop and pilot scale equipment procurement and operation, analytical testing of equipment, and summarization of data and results.
• Responsible for engineering, operations, and maintenance requirements for large scale process equipment.
• Lead for development of new processes and unit operations.
• Responsible for process modeling and consulted on process fit and throughput assessments.
• Responsible for planning and operating lab scale and pilot equipment for development of new unit operations.
• Generate reports for engineering teams to specify equipment based on lab scale development operations.
• Responsible for process design review for large capital projects, including user requirements specifications development, P&IDs, layouts, and equipment specifications.
• Responsible for equipment requirements definition and procurement support, including equipment and instrumentation specification/selection, equipment procurement, FAT/SAT, installation, commissioning, qualification, and turn-over to manufacturing.
• Consulted on Automation/Controls design, including instrumentation selection, equipment interface, and equipment module / phase design.
• Support Chemical Development in the development, characterization, and scaleup of innovative Oligonucleotide production processes and technologies.
• Support EHS activities including PHA, PSSR, and PSM compliance.

Qualifications

• Bachelor's or Master's Degree in Chemical Engineering or equivalent engineering education/experience.
• 2+ years of combined experience in pharma/biopharma, fine chemicals or food manufacturing industries to include experience with P&IDs, facility layouts, mass and energy balances, solvent handling, equipment design, user requirement specifications (URSs).
• 2+ years of experience with medium to large-sized projects through all phases, including design, design review, process hazard analysis, equipment procurement, installation, commissioning, and qualification.
• Familiarity with current ASME BPE sanitary piping and equipment design standards, electrical standards such as National Fire Protection Association / National Electrical Code (NFPA 70 / NEC), and International Fire and Building Code.
• Experience in laboratory environment including laboratory notebook data integrity and good documentation practices, chemical and solvent handling, and operation of analytical testing instrumentation including HPLC, GC, and UV-Vis.
• Internships or co-ops in the biopharma or chemical industry a plus.
• Engineering, communication, and organizational skills to support the safe, efficient, and compliant design, construction, and startup of an API manufacturing facility.
• Self-motivated, hands-on problem solver with the ability to work within multi-disciplinary teams, including process development, manufacturing, validation, quality, safety, and project management personnel.