Tech Transfer Process EngineerLocation: Spokane, WA (Onsite)
Duration: Contract
Job Summary
We are seeking an experienced Tech Transfer Process Engineer to support New Product Introduction (NPI) and technology transfer activities within a pharmaceutical manufacturing environment. The successful candidate will play a key role in transferring incoming client products into manufacturing, coordinating cross-functional activities, authoring transfer documentation, and supporting process implementation.
This position requires strong experience in technology transfer, CDMO operations, risk assessments, deviations, change controls, and hands-on manufacturing support.
Key Responsibilities
- Lead and support NPI and technology transfer activities for incoming client programs.
- Develop transfer plans, process documentation, and process control strategies.
- Coordinate technical turnover activities between development and manufacturing teams.
- Support process implementation and manufacturing readiness activities.
- Conduct risk assessments and identify process improvement opportunities.
- Author and review SOPs, batch records, protocols, and transfer documentation.
- Collaborate with internal stakeholders and external clients throughout the transfer lifecycle.
- Support manufacturing floor activities and troubleshoot process-related issues.
- Manage deviations, change controls, investigations, and study closeout reports.
- Ensure compliance with GMP regulations and site procedures.
Required Qualifications
- Bachelor's degree in Engineering, Biotechnology, Life Sciences, or related discipline.
- 8+ years of pharmaceutical, biotechnology, or biologics manufacturing experience.
- Strong Technology Transfer and New Product Introduction (NPI) experience.
- Experience working in a CDMO or CMO environment.
- Knowledge of GMP-regulated manufacturing operations.
- Experience with risk assessments, deviations, and change controls.
- Strong technical writing and documentation skills.
- Ability to work directly on the manufacturing floor and support operations.
- Excellent communication and client-facing skills.
Preferred Qualifications
- Experience supporting multiple concurrent technology transfer projects.
- Experience with process development and manufacturing scale-up activities.
- Familiarity with aseptic or sterile manufacturing operations.
- Strong cross-functional collaboration skills.
Required Skills
Technology Transfer, NPI, New Product Introduction, Technical Transfer, Process Transfer, CDMO, Pharmaceutical Manufacturing, GMP, Risk Assessment, Change Control, Deviations, SOP Authoring, Batch Records, Process Documentation, Technical Writing, Manufacturing Support, Process Development, Client-Facing Communication.