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Project Engineer, Mechanical Support

Organization
Agilent
Job Location
7051 Eagle Blvd
Longmont, CO 80504
United States
Job Description

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 sophisticated manufacturing processes and transform broad concepts into structured results-focused projects.

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

 Duties and Responsibilities include:

  • 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 Project Team and Facilities/Engineering Team with day-to-day troubleshooting and maintenance activities, identification of process improvement and optimization opportunities, review of SOP, and CMMS Assets.
  • Provide support and serve as SME for unit operations such as Tank Farm, Process Utilities, and unit operations as needed or advised.
  • Provide build-out of CMMS for small and large capital processes.
  • Support EHS activities including PHA, PSSR, Permitting, 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.
Requirements

QualificationsRequired

  • Bachelors or Masters Degree in Chemical Engineering or equivalent education/experience
  • 2+ years of combined experience in pharma/biopharma and fine chemicals industry to include experience with the operation of unit operations for the manufacture of Active Pharmaceutical Ingredient, Solid Dosage Form, or biologic.
  • Experience with reading P&IDs, facility layouts, solvent handling, standard operating procedures (SOPs) and process troubleshooting.

Desired

  • Familiarity with sanitary piping and equipment
  • Experience with industrial control systems including SCADA, PLCs, and BAS
  • Familiar with 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.
  • 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.
  • Experience with EHS Permitting with solvents
  • Planning and Coordination
  • PSM, reaction vessels, and reagent charging a plus

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