JOB DESCRIPTION

?What’s it like to work at Agilent in Manufacturing? Watch the video?
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 Process Engineer at our Boulder, 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:

• Provide project/process engineering support of a GMP manufacturing process (Upstream, Midstream, Downstream, Utilities).
• Responsible for any area of focus with the existing manufacturing process. Area of focus will also be supported during projects.
• Supporting small to large sized capital projects throughout all phases of the project lifecycle, including the development of user requirement specifications, process design integration, equipment and instrumentation specification/selection, equipment procurement, installation, commissioning, qualification, and turn-over to manufacturing.
• Participate with project management through coordination of multi-disciplinary teams.
• Collaborate with Chemical Development and Manufacturing Services groups with activities such as technical transfer and scale-up of processes into manufacturing.
• Collaborate and facilitate project EHS activities including Process Hazard Analysis, Safety Checklist, and PSM compliance to meet OSHA standards.
• Ensure for all projects a high level of cGMP compliance to meet the ICH requirements for pharmaceutical buildouts.
• 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 regulatory activities including writing, review, and/or resolution of Change Controls (CC/CSC), Corrective and Preventive Actions (CAPAs), and audit responses.
• Integrate with Manufacturing and Quality Assurance groups with day-to-day troubleshooting and maintenance activities for projects/process, through identification of process improvement and optimization opportunities, including review of SOPs and MBRs.
• Perform job functions and responsibilities independently and with limited direction.
• Leads the development, design of new product/ process technology advancements; is the key technical contributor.
• Solves complex, high impact design/ development problems.

QUALIFICATIONS

• Bachelor’s or Master’s Degree in Mechanical, Electrical, or 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 process and instrumentation diagrams, facility layouts, equipment sizing calculations, user requirement specifications (URSs), standard operating procedures (SOPs) and process troubleshooting.

Preferred Skills:

• 2+ years of experience supporting small to large-sized projects through all phases, including architectural and engineering design, design review, process safety management, 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.
• 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 Codes.
• Project Management experience in biopharma.
• 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.
• Engineering, communication, and organizational skills to support the safe, efficient, and compliant production of API within a fast-paced, dynamic, contract manufacturing facility.

LI-DT1

• Provide project/process engineering support of a GMP manufacturing process (Upstream, Midstream, Downstream, Utilities).
• Responsible for any area of focus with the existing manufacturing process. Area of focus will also be supported during projects.
• Supporting small to large sized capital projects throughout all phases of the project lifecycle, including the development of user requirement specifications, process design integration, equipment and instrumentation specification/selection, equipment procurement, installation, commissioning, qualification, and turn-over to manufacturing.
• Participate with project management through coordination of multi-disciplinary teams.
• Collaborate with Chemical Development and Manufacturing Services groups with activities such as technical transfer and scale-up of processes into manufacturing.
• Collaborate and facilitate project EHS activities including Process Hazard Analysis, Safety Checklist, and PSM compliance to meet OSHA standards.
• Ensure for all projects a high level of cGMP compliance to meet the ICH requirements for pharmaceutical buildouts.
• 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 regulatory activities including writing, review, and/or resolution of Change Controls (CC/CSC), Corrective and Preventive Actions (CAPAs), and audit responses.
• Integrate with Manufacturing and Quality Assurance groups with day-to-day troubleshooting and maintenance activities for projects/process, through identification of process improvement and optimization opportunities, including review of SOPs and MBRs.
• Perform job functions and responsibilities independently and with limited direction.
• Leads the development, design of new product/ process technology advancements; is the key technical contributor.
• Solves complex, high impact design/ development problems