The Specific Pay Range For A Preferred Location

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 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.

Problems you'll solve

Problem-solving; Trouble-shooting; Root cause analysis

Eligibility Requirements

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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