Process Engineer, Upstream

Agilent Technologies•Frederick, CO

3d•Onsite

About The Position

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 Upstream Process Engineer. Work on a dynamic, fast-paced, large capacity oligonucleotide API production facility design and construction project. Contribute to the growing industry of oligonucleotide (DNA-RNA) based therapeutics.

Requirements

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 (URSs).
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.

Nice To Haves

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 upstream unit operations and processes including: column packing, solid phase organic synthesis, solution preparation, reagent preparation, deprotection, ultrafiltration, and organic waste systems.
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.
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.

Responsibilities

Technical lead for upstream 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.
Responsible for planning, review, and execution of process startup, commissioning, and qualification activities.
Consulted on project management aspects including project schedule, budget, and coordination of multi-disciplinary teams.
Support EHS activities including PHA, PSSR, and PSM compliance.