Agilent Technologies
Biopharma
ManufacturingEngineer
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Manufacturing Engineer at Agilent Technologies. Skills: Process transfer, Manufacturing support, Problem-solving. Transfer processes from Chemical Development. Scale-up new processes”
Industry & Context.
Problem-solving; Trouble-shooting; Root cause analysis
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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