Tech Transfer Process Engineer

Stark Pharma Solutions Inc; Seattle (WA); Presencial; USD 120.000 - 160.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Conocimientos

Client-facing communication

Technical writing

Hands-on

Problem solving

Educación

Bachelor's degree with Chemical Engineering preferred

Descripción del empleo

About The Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position

Tech Transfer Process Engineer

Location

Washington

Duration

Long Term

Job Overview

We are seeking a Tech Transfer Process Engineer to support NPI and technical transfer activities in a sterile aseptic fill-finish pharmaceutical manufacturing environment.

Key Responsibilities

• 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.

Required Qualifications

• 8 10 years of pharmaceutical industry experience.
• CDMO experience in a fast‑paced environment.
• Sterile/aseptic fill‑finish experience.
• Hands‑on experience working on manufacturing lines.
• NPI and technical transfer experience.
• Experience with process development and validation.
• Experience with risk assessments and protocol writing.
• Experience with change controls and deviations.
• Strong technical writing and documentation skills.
• Strong client‑facing communication skills.
• Confident, organized, and hands‑on.
• Bachelor s degree preferred; Chemical Engineering is a plus.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.