NPI Process Transfer Engineer (Sterile Fill-Finish)

United Pharma; Washington; On-site; USD 120,000 - 160,000; Full time

Job summary

United Pharma is seeking a Process Engineer to support the transfer of new products into a CDMO manufacturing site, collaborating with clients and cross-functional teams to ensure successful process transfer, development, and validation.

This hands-on manufacturing-floor role focuses on NPI technical transfers, process development, risk assessment, batch execution, and technical documentation to drive manufacturing readiness.

Qualifications

• Must have extensive experience with technology transfer in pharma manufacturing.
• Strong knowledge of GMP and regulatory expectations for sterile fill-finish operations.
• Proven ability to develop transfer plans, control strategies, and technical documentation.

Responsibilities

• Lead and support NPI technical transfer activities for sterile/aseptic fill-finish products.
• Collaborate with clients to gather and evaluate product, process, and technical data.
• Develop and author Technical Transfer Plans, Process Control Strategies, and transfer documentation.
• Coordinate activities to develop, establish, and validate processes at the site.
• Perform process risk assessments and identify mitigation strategies.
• Develop and execute hands-on batch sampling and process study protocols.
• Provide on-floor engineering support during manufacturing runs and process trials.
• Support change controls, deviations, investigations, and corrective actions.
• Ensure activities comply with GMP, site procedures, and pharmaceutical regulations.

Skills

NPI transfer

Process development

Risk assessment

On-floor manufacturing

Client communication

GMP compliance

Cross-functional collaboration

Process validation

Job description

United Pharma is seeking a Process Engineer to support the transfer of new products into a CDMO manufacturing site, collaborating with clients and cross-functional teams to ensure successful process transfer, development, and validation.

This hands-on manufacturing-floor role focuses on NPI technical transfers, process development, risk assessment, batch execution, and technical documentation to drive manufacturing readiness.