Process Engineer

Process Engineer

Requirements

• Bachelor’s or Master’s Degree in Chemical Engineering or equivalent education/experience
• 4+ years of combined experience in pharma/biopharma and fine chemicals industry
• 3+ years of experience with P&IDs, facility layouts, mass and energy balances, solvent handling, equipment sizing calculations, user requirement specifications (URSs), standard operating procedures (SOPs), and process troubleshooting
• 3+ years of experience managing small to large-sized projects through all phases, including design, design review, process hazard analysis, equipment procurement, installation, commissioning, and qualification

Responsibilities

• Support the Manufacturing group with day-to-day troubleshooting and maintenance activities, identification of process improvement and optimization opportunities, review of SOPs and MBRs
• Responsible for small to large sized capital projects throughout all phases of the project lifecycle, including the development of user requirement specifications, process design, equipment and instrumentation specification/selection, equipment procurement, installation, commissioning, qualification, and turn-over to manufacturing
• Responsible for project management aspects, including project schedule, budget, and coordination of multi-disciplinary teams
• Support Chemical Development and Manufacturing Services groups with activities such as technical transfer and scale-up of processes into manufacturing
• Support EHS activities including PHA, PSSR, and PSM compliance
• Support Validation activities including review of Factory Acceptance Test and Site Acceptance Test (FAT/SAT) protocols and participating in FAT/SAT execution, review of installation, operational, and performance qualification (IQ/OQ/PQ) protocols, participating in IOPQ execution, and review of final reports
• Support Quality Assurance activities including writing, review, and/or resolution of Change Controls (CC/CSC), Corrective and Preventive Actions (CAPAs), and audit responses
• Perform job functions and responsibilities independently and with limited direction

Preferred 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 design and programming of industrial control systems, including SCADA, PLCs, and BAS, and validation documentation, including installation, operational, and performance qualification (IQ/OQ/PQ) protocols
• Ability to use AutoCAD or Visio
• Engineering, communication, and organizational skills to support the safe, efficient, and compliant production of API within a fast-paced, dynamic, contract 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