Agilent Technologies

Biopharma

ManufacturingEngineer

$103–161k Frederick, Colorado, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“Manufacturing Engineer at Agilent Technologies. Skills: Process transfer, Manufacturing support, Problem-solving. Transfer processes from Chemical Development. Scale-up new processes”

Industry & Context.

Biopharma
Problems you'll solve

Problem-solving; Trouble-shooting; Root cause analysis

Eligibility Requirements

Occasional travel

What They're Looking For.

Must Have

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

Nice to Have

Prior experience in GMP manufacturing facility

What You'll Do.

Transfer processes from Chemical Development

Scale-up new processes

Participate in project team meetings

Develop project plans

Execute project plans

Interface with Chemical Development

Interface with Manufacturing

Approve technology transfer documents

Write process documentation

Review process documentation

Write master batch records

Write data capture forms

Write automated equipment methods

Coordinate SOP revision

Scale-up existing processes

Write batch documentation

Write change controls

Write automated equipment methods

Coordinate SOP creation

Coordinate SOP revision

Generate batch summaries

Review batch summaries

Communicate development requirements

Communicate development opportunities

Assist manufacturing with problem-solving

Troubleshoot process equipment

Interface with external vendors

Interface with customers

Lead investigation of deviations

Participate in deviation investigation

Provide technical assistance to QA

Assess product impact

How You'll Work.

Team & Collaboration

Project team meetings; Interface with Chemical Development; Interface with Manufacturing; Technical assistance to QA

Communication Scope

Communicate requirements; Communicate opportunities; Discuss issues

Process & Methodology

Project plans

Full Job Description

## **Job Description** The world's most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in capacity and expansion of its Colorado operations. Join our team of professionals dedicated to the development and commercialization of nucleic acid therapeutics for life changing, lifesaving medicines. The Manufacturing Engineer position performs a wide variety of technical duties to support manufacturing operations. * 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. Responsible for the review and approval of technology transfer documents from Chemical Development. * Responsible for writing or reviewing 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. * Responsible for writing and/or reviewing; 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. * Responsible for the generation and/or review of batch summaries for all batches produced in the manufacturing facilities. * Responsible for communicating 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 to clearly and concisely discuss and resolve the issue to meet production timelines, quality policies, and customer expectations. * Actively lead or participate in the invest

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