Process Engineer, Downstream

Responsibilities

• Technical lead for downstream processes and unit operations.
• Responsible for process modeling and consulted on process fit and throughput assessments.
• Responsible for process design review for large capital projects, including user requirements specifications development, P&IDs, layouts, and equipment selection.
• Responsible for equipment design 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.
• Responsible for Building Information Model (BIM) review for process piping and equipment, cleanroom design, and general spatial planning to achieve manufacturing requirements.
• Supported 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 education/experience.
• 8+ years of combined experience in pharma/biopharma and fine chemicals industry to include experience with P&IDs, facility layouts, mass and energy balances, solvent handling, equipment design, user requirement specifications (URS).
• 6+ 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.

Desired Qualifications

• 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 with Oligonucleotide manufacturing downstream unit operations and processes including: Column packing, preparative liquid chromatography, buffer preparation, reaction, ultrafiltration, evaporation, drying.
• Experience with design of industrial control systems, including SCADA, PLCs, and BAS, and validation documentation, including installation, operational, and performance qualification (IQ/OQ/PQ) protocols.
• Experience and familiarity with OSHA Process Safety Management (PSM) program requirements.
• 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.