Senior Process Engineer

IT MINDS L.L.C.

Spokane, WA
2 days ago

Want to know if you’re a fit?
Upload your resume and let our AI show you.

Skills

Communication Skillsunmatched
Cross-Functionalunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Documentationunmatched
Documentation Reviewunmatched
Drug Manufacturingunmatched
Drug Productsunmatched
Identify Issuesunmatched
Leadershipunmatched
Manufacturingunmatched
Manufacturing Requirementsunmatched
Manufacturing/Industrial Processesunmatched
Process Analysisunmatched
Process Control Engineeringunmatched
Process Developmentunmatched
Process Engineeringunmatched
Process Validationunmatched
Project Executionunmatched
Team Lead/Managerunmatched
Technical Leadershipunmatched
Technical Supportunmatched
Technical Writingunmatched
Time Managementunmatched
Validation Planunmatched

Description

Job Title:Senior Process Engineer Fill/Finish Technology TransferLocation:Spokane WashingtonDuration:ContractJob Description: We are seeking a highly experienced Senior Process Engineer to lead a large-scale Fill/Finish Technology Transfer project within a pharmaceutical manufacturing environment. The ideal candidate will have extensive experience in sterile drug product manufacturing, process validation, and technology transfer, with the ability to independently lead cross-functional teams and drive project execution from planning through commercialization. Responsibilities

Lead end-to-end Fill/Finish technology transfer activities.
Review and assess process documentation, batch records, and technology transfer packages.
Identify documentation and process gaps and drive timely resolution.
Develop and implement process control strategies supporting validation and commercial manufacturing.
Lead engineering, PPQ, validation, and commercial batch execution.
Develop and own the process validation strategy.
Provide technical leadership and guidance for validation protocols and reports.
Collaborate with Manufacturing, Engineering, Quality, Validation, and external clients.
Serve as the technical lead for successful technology transfer execution.

Required Qualifications

Extensive experience with Fill/Finish Technology Transfer.
Strong background in sterile pharmaceutical manufacturing.
Hands-on experience supporting Engineering, PPQ, Validation, and Commercial batches.
Expertise in Process Validation and Process Control Strategy.
Strong understanding of cGMP regulations and pharmaceutical manufacturing.
Excellent troubleshooting, leadership, and communication skills.

Preferred Qualifications

Drug Product manufacturing experience.
Experience leading cross-functional technical teams.
Strong documentation review and technical writing support experience.

Numbers & Facts

Location

Spokane, WA

Resume Resources

Free Resume Templates Free Resume Builder