Tech Transfer Process Engineer

United Pharma; Washington; On-site; USD 120,000 - 180,000; Full time

Job summary

United Pharma seeks experienced engineers for NPI technical transfer in a sterile aseptic fill-finish environment. You will perform tech transfers with incoming clients, author process controls, and lay out activities for process development and validation at the site.

Responsibilities include risk assessment, hands-on batch samples protocol writing, and collaboration with clients, with involvement in change controls, deviations, and written reports to close out studies focused on incoming NPI

Qualifications

• 8-10 years within pharmaceutical experience.
• Aseptic sterile, fill finish experience, working on lines.
• NPI technical transfer experience.
• Must be hands on and willing to work on the manufacturing floor.

Responsibilities

• Perform risk assessment and write batch samples protocol.
• Collaborate with clients on tech transfers and validation plans.
• Contribute to change controls, deviations, and close-out reports.
• Develop process transfer plans and document technical turnover for site.

Skills

Pharma industry experience

CDMO background

Aseptic fill finish

NPI technical transfer

Hands-on manufacturing floor

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