Manufacturing Engineer

Agilent Technologies•Boulder, CO

18d•$103,200 - $161,250•Onsite

About The Position

The Manufacturing Engineer position performs a wide variety of technical duties to support manufacturing operations. This role involves the transfer and scale-up of new processes from Chemical Development into Manufacturing, attending project team meetings to develop and execute project plans, and interfacing with Chemical Development and Manufacturing to ensure small-scale development activities will scale to manufacturing equipment and systems. The position is responsible for the review and approval of technology transfer documents, writing or reviewing new process documentation (master batch records or data capture forms) and automated equipment methods, and coordinating the revision of standard operating procedures (SOPs) as required to support the transfer. Additionally, the role involves scaling up existing processes in Manufacturing, including writing and/or reviewing scale-up batch documentation, change controls, automated equipment methods, and coordinating the creation and/or revision of SOPs. The Manufacturing Engineer is also responsible for the generation and/or review of batch summaries, communicating future development requirements or opportunities, and assisting manufacturing with problem-solving and troubleshooting process or process equipment, including interfacing with external vendors and customers. The role actively leads or participates in the investigation of major process deviations, providing technical assistance to Quality Assurance (QA) on product impact assessment and root cause identification.

Requirements

Bachelor’s or Master’s Degree or equivalent
4+ years of relevant experience in technical operations or manufacturing
Experience with technical transfer and supporting manufacturing troubleshooting
Skilled in authoring batch records, change controls, deviations, SOPs, and CAPAs

Nice To Haves

Prior experience in a GMP manufacturing facility preferred

Responsibilities

Transfer and scale-up of new processes from Chemical Development into Manufacturing.
Attend and participate in project team meetings to develop and execute project plans.
Interface with Chemical Development and Manufacturing to ensure small-scale development activities will scale to manufacturing equipment and systems.
Review and approve technology transfer documents from Chemical Development.
Write or review new process documentation (master batch records or data capture forms) and automated equipment methods.
Coordinate the revision of standard operating procedures (SOPs) as required to support the transfer.
Scale-up existing processes in Manufacturing.
Write and/or review scale-up batch documentation, change controls and automated equipment methods.
Coordinate the creation and/or revision of SOPs as required to support the scale-up.
Generate and/or review batch summaries for all batches produced in the manufacturing facilities.
Communicate future development requirements or opportunities to the project team.
Assist manufacturing with problem-solving and trouble-shooting process or process equipment including interfacing directly with external vendors and customers.
Actively lead or participate in the investigation of major process deviations including providing technical assistance to Quality Assurance (QA) on the final product impact assessment and identification of root cause as necessary.