The Specific Pay Range For A Preferred Location
ManufacturingEngineer
Neural analysis suggests this role is
optimal for Mid candidates.
“Manufacturing Engineer at The Specific Pay Range For A Preferred Location. Skills: Process scale-up, Manufacturing support, Documentation authoring. Transfer new processes. Scale-up new processes”
Industry & Context.
Problem-solving; Trouble-shooting; Root cause analysis
Occasional travel
What They're Looking For.
Must Have
4+ years relevant experience, Technical operations experience, Manufacturing experience, Technical transfer experience, Manufacturing troubleshooting experience, Authoring batch records, Authoring change controls, Authoring deviations, Authoring SOPs, Authoring CAPAs
Nice to Have
GMP manufacturing facility experience
What You'll Do.
Transfer new processes
Scale-up new processes
Participate in project meetings
Develop project plans
Execute project plans
Interface with Chemical Development
Interface with Manufacturing
Review technology transfer documents
Write new process documentation
Review new process documentation
Write master batch records
Review master batch records
Write data capture forms
Review data capture forms
Write automated equipment methods
Review automated equipment methods
Coordinate SOP revision
Scale-up existing processes
Write batch documentation
Scale-up batch documentation
Write change controls
Scale-up change controls
Write automated equipment methods
Scale-up 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 deviation investigation
Participate in deviation investigation
Provide technical assistance to QA
Assess product impact
How You'll Work.
Team & Collaboration
Project team meetings; Chemical Development; Manufacturing; Quality Assurance
Communication Scope
Communicate requirements; Discuss issues
Process & Methodology
Project planning
Full Job Description
## **Job Description** 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 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. ## ## **Qualifications** * Bachelor’s or Master’s Degree or equivalent * 4+ years of relevant experience in technical operations or manufacturing * Experience with technical trans
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