What are the responsibilities and job description for the Senior Process Engineer position at IT Minds LLC?
Job Title: Senior Process Engineer Fill/Finish Technology Transfer Location: Spokane Washington Duration: Contract Job 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.
- 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.
- Drug Product manufacturing experience.
- Experience leading cross-functional technical teams.
- Strong documentation review and technical writing support experience.