Tech Transfer Process Engineer

United Pharma; Washington; On-site; USD 90,000 - 145,000; Full time

Job summary

United Pharma is seeking a hands-on Process Engineer for NPI technical transfer in a sterile aseptic fill-finish environment in Washington. You will lead tech transfers with incoming clients, author process controls, and develop transfer plans while coordinating activities to validate site processes.

The role requires risk assessment, batch protocol writing, and close collaboration with clients, with a focus on technical turnover and data-driven transfer activities on the manufacturing floor.

Qualifications

• 8-10 years of pharmaceutical experience.
• CDMO background in high-paced environments.
• Aseptic sterile fill-finish experience on production lines.
• NPI technical transfer experience.
• Must be hands-on on the manufacturing floor.

Responsibilities

• Assist with NPI technical transfers and technical turnover.
• Prepare and review data surrounding products and write batch protocols.
• Draft and execute transfer plans and process controls.
• Collaborate with clients and perform risk assessments.
• Contribute to change controls, deviations, and close-out reports.

Skills

Pharma experience

CDMO background

Aseptic fill-finish

NPI technical transfer

Hands-on on the manufacturing floor

Client facing

Organized

Education

Chemical Engineering degree preferred

Job description

The client needs help with their NPI technical transfer work. This will be a sterile aseptic fill finish environment that will require the process engineers to be doing tech transfers with incoming clients. The project will focus on technical turnover with data surrounding products, authoring process control, transfer plans and laying out the activities that develop the process and validate the site. The contractors will be responsible for risk assessment, hands-on-on-batch samples protocol writing, and collaboration with clients. There will be work with change controls, deviations and written reports to close out the studies, however most of the work will be revolved around incoming NPI transfers.

Skills/ Background:

• 8-10 years within pharmaceutical experience
• CDMO background willing to work in high pace environments
• Aseptic sterile, fill finish experience, working on lines
• NPI Technical Transfer experience
• Must be hands on and willing to work on the manufacturing floor

Soft skills:

Client facing, confident and organized, hands on

Degree:

Preferred and not required. Chemical Engineering could be beneficial