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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 a 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 design and construction activities for newly created capital projects from concept design through validation of new processes. Including working hand in hand with A&E and all other cross-functional teams.
- 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.
The salary range for this position in Frederick, CO is currently $67,980 - $105,750.
7051 Eagle Blvd
Frederick, CO 80504
- Bachelors or master’s degree in chemical engineering or equivalent education/experience
- 2+ 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.
- 1 + 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.
- 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.
- Engineering, communication, and organizational skills to support the safe, efficient, and compliant production of API within a fast-paced, dynamic, contract manufacturing facility.