Process Engineer

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek ---- so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.

Want to take your knowledge and experience further? Ready to provide technical leadership and make key decisions? This is your opportunity - not only to join a committed, professional, and forward-thinking team but also to lead in the design and implementation of complex manufacturing processes and transform broad concepts into structured results-focused projects.

Join a growing team with this exciting new opportunity for an expert level Process Engineer at our Frederick, Colorado GMP facility. Work in our dynamic, fast-paced, API-Biopharma manufacturing environment with the ability to contribute to the growing industry of oligonucleotide (DNA-RNA) based therapeutics.

Responsibilities may include but are not limited to:

• 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.

• 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 to include 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, is desirable.

Desired

• 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.

Additional Details