Tech Transfer Process Engineer

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

The Process Engineer will support the transfer of new products into a CDMO manufacturing site, working closely with clients and cross-functional teams to ensure successful process transfer, development, and validation.

This is a hands-on manufacturing-floor role focused primarily on incoming NPI technical transfers, process development, risk assessment, batch execution, and technical documentation.

Key Responsibilities:

• Lead and support NPI technical transfer activities for sterile/aseptic fill-finish products.


• Collaborate directly 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 required to develop, establish, and validate processes at the manufacturing site.


• Perform process risk assessments and identify potential manufacturing risks and mitigation strategies.


• Develop and execute hands-on batch sampling and process study protocols.


• Provide on-floor engineering support during manufacturing runs, process trials, and technical transfer activities.


• Support change controls, deviations, investigations, and corrective actions associated with transferred products.


• Ensure activities are completed in accordance with GMP, site procedures, and applicable pharmaceutical regulations.

Required Skills & Experience:

• 8-10+ years of pharmaceutical industry experience.


• Strong CDMO experience in a fast-paced manufacturing environment.


• Hands-on experience with sterile/aseptic fill-finish manufacturing.


• Experience working directly on or supporting commercial/manufacturing lines.


• Proven experience with NPI and technical transfer activities.


• Strong understanding of process development, process validation, and manufacturing readiness.


• Experience with risk assessments, protocols, change controls, deviations, and technical reports.


• Comfortable working directly with clients and cross-functional teams.


• Must be hand-on and willing to work on the manufacturing floor.