Tech Transfer Engineer – Sterile Fill-Finish

Stark Pharma Solutions Inc; Seattle (WA); Presencial; USD 120.000 - 160.000; Tempo integral

Resumo da vaga

Stark Pharma Solutions Inc. is seeking a Tech Transfer Process Engineer to support NPI and technical transfer activities in a sterile aseptic fill-finish pharmaceutical manufacturing environment in Washington state.

The role requires 8–10 years of pharmaceutical industry experience, CDMO exposure, and strong technical writing and client-facing communication skills. You will collaborate with Manufacturing, Quality, Validation, and Engineering teams on process development, transfers, and process

Qualificações

• 8–10 years of pharmaceutical industry experience.
• CDMO experience in a fast-paced environment.
• Sterile/aseptic fill-finish experience.
• NPI and technical transfer experience.
• Process development and validation experience.
• Risk assessments and protocol writing experience.
• Change controls and deviations experience.
• Strong technical writing and documentation skills.
• Strong client-facing communication skills.
• Bachelor's degree preferred; Chemical Engineering is a plus.

Responsabilidades

• Support NPI and technical transfer activities for incoming client products.
• Develop technical transfer and process control plans.
• Review product and process data for technology transfers.
• Support process development and validation activities.
• Write and execute batch sampling and process study protocols.
• Perform process risk assessments.
• Work directly with clients on technical transfer activities.
• Support change controls and deviation investigations.
• Prepare technical reports and study closeout documentation.
• Collaborate with Manufacturing, Quality, Validation, and Engineering teams.
• Provide hands‑on support on the manufacturing floor.
• Support troubleshooting and process improvement activities.

Conhecimentos

Client-facing communication

Technical writing

Hands-on

Problem solving

Formação

Bachelor's degree with Chemical Engineering preferred

Descrição da vaga

Stark Pharma Solutions Inc. is seeking a Tech Transfer Process Engineer to support NPI and technical transfer activities in a sterile aseptic fill-finish pharmaceutical manufacturing environment in Washington state.

The role requires 8–10 years of pharmaceutical industry experience, CDMO exposure, and strong technical writing and client-facing communication skills. You will collaborate with Manufacturing, Quality, Validation, and Engineering teams on process development, transfers, and process