Project Engineer

Job Description

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 a Process/Project 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. This role will support an exciting project that is expected to significantly grow and expand the Oligo-manufacturing capability of our Colorado sites.

Responsibilities may include, but are not limited to:

• Support design, construction, commissioning and qualification activities for newly created capital projects from concept design through validation of new processes. Work hand in hand with Design Firm, Equipment, Suppliers, and all other cross-functional teams.

• Responsible for supporting a variety of 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 turnover to manufacturing.

• Primary immediate responsibility will be supporting the existing large-scale capital project. Brownfield construction ~80% completed. The candidate will function as a process engineer responsible for a designated area of ownership within the project and manufacturing area.

• Responsible for project management aspects, including project schedule, budget, and coordination of multi-disciplinary teams.

• Support Environmental Health & Safety activities, including Process Hazard Analysis, Pre-Startup Safety Review, and Process Safety Management 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.

Qualifications

• Bachelor's or Master's Degree in Mechanical, Electrical, Chemical (or BioChem), Manufacturing Engineering, or equivalent education/experience.

• 4-6+ years of combined experience in a FDA regulated environment such as: pharma/biopharma and/or 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.

• 2+ years of experience participating in small to large-sized projects through all phases, including design, design review, process hazard analysis, equipment procurement, installation, commissioning, and qualification, is desirable

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 Codes.

• Experience with Biotechnology equipment platforms (Purification, Ultrafiltration, Clean In Place, etc).

• Experience with industrial control systems, including SCADA, PLCs, and BAS, and validation documentation, including installation, operational, and performance qualification (IQ/OQ/PQ) protocol