Manufacturing Engineer STS Technical Services
West Point, MS14 days ago
Highlights
The ideal candidate will have extensive experience in drug product manufacturing, process validation, and technology transfer, with the ability to provide technical leadership throughout process implementation, validation, and commercial readiness. We are seeking an experienced Senior Process Engineer to lead large-scale fill/finish technology transfer activities within a GMP pharmaceutical manufacturing environment.
Numbers & Facts
| Location | west point, WA |
Description
Position: Senior Process Engineer
Location: West Point, WA
Duration: Long Term
Job Overview
We are seeking an experienced Senior Process Engineer to lead large-scale fill/finish technology transfer activities within a GMP pharmaceutical manufacturing environment. The ideal candidate will have extensive experience in drug product manufacturing, process validation, and technology transfer, with the ability to provide technical leadership throughout process implementation, validation, and commercial readiness.
Key Responsibilities
- Lead end-to-end fill/finish technology transfer activities from project initiation through execution.
- Review and assess existing process, batch, and technology transfer documentation, identifying gaps and driving resolution.
- Develop and implement process control strategies to support technology transfer and validation activities.
- Lead engineering, PPQ, and validation batch execution.
- Develop and oversee validation strategies while providing technical guidance to cross-functional teams.
- Support the preparation and review of validation protocols, reports, and technical documentation.
- Collaborate with Manufacturing, Quality, Validation, Engineering, and other stakeholders to ensure successful project execution.
- Provide technical leadership to ensure compliance with GMP requirements and project timelines.
Required Qualifications
- Bachelor's degree in Engineering or a related technical discipline.
- Minimum 5 years of Process Engineering experience in pharmaceutical or biotech manufacturing.
- Strong experience in drug product manufacturing and fill/finish operations.
- Hands-on experience with technology transfer, process validation, and PPQ batch execution.
- Knowledge of aseptic processing and GMP pharmaceutical manufacturing.
- Experience developing process control and validation strategies.
- Strong technical writing, troubleshooting, and cross-functional collaboration skills.
- Ability to lead complex engineering projects in a regulated manufacturing environment.