Tech Transfer Process Engineer

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.

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.

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.