Senior Process Engineer - Sterile Injectables

Senior Process Engineer | Sterile Injectables

Location: Washington State

Start Date: Mid to Late October

Duration: 6+ Months | Temp-to-Perm

About the Role:

BioSpear Consulting Group is seeking a Senior Process Engineer to support sterile injectable manufacturing operations in Washington State.

This role is focused on technology transfer, aseptic fill/finish, and Process Performance Qualification (PPQ), supporting products from process transfer and manufacturing readiness through validation and routine production.

The ideal candidate has hands-on experience transferring sterile drug product processes into manufacturing environments and can work cross-functionally with Manufacturing, Quality, and Engineering to establish robust processes, lead validation activities, and troubleshoot manufacturing challenges.

Key Responsibilities:

• Lead technology transfer of sterile injectable products into manufacturing
• Perform process fit assessments, identify gaps, and support site and manufacturing readiness
• Define and evaluate critical process parameters (CPPs) and critical quality attributes (CQAs)
• Develop and execute PPQ protocols, validation studies, sampling plans, and final reports
• Provide hands-on support for aseptic fill/finish manufacturing operations
• Troubleshoot process issues, investigate deviations, and support CAPA development and implementation
• Analyze manufacturing data and process trends to support continued process verification and continuous improvement
• Coordinate cross-functional activities and communicate technical requirements, risks, and results

Qualifications

• Strong experience in sterile injectable manufacturing
• Demonstrated expertise in technology transfer, aseptic fill/finish, and PPQ
• Strong knowledge of cGMP requirements and aseptic processing principles
• Experience with sterilization, contamination control, and cleanroom operations
• Bachelor’s degree in Engineering, Science, or a related discipline
• Strong technical writing, communication, and project management skills
• Lyophilization experience is preferred

This is an excellent opportunity for an experienced process engineer who enjoys being close to manufacturing and helping bring sterile products successfully through transfer, validation, and commercial production.

NOTE: Agencies, C2C, or Business Partner submissions will not be considered