Senior Process Engineer

Overview:
Our client is seeking a Lead Process Engineer to guide and execute a large-scale fill/finish technology transfer. This role requires a senior, hands-on engineer who can walk into a site, assess existing documentation and processes, and lead the end-to-end tech transfer effort. The Lead Process Engineer will provide technical direction, validation strategy, and process control guidance, with dedicated document writing support provided. Drug product experience is highly preferred.

Key Responsibilities:

• Lead large-scale fill/finish technology transfer activities from site intake through execution
• Review and assess existing process, batch, and tech transfer documentation; identify gaps and drive resolution
• Define and map the process control strategy in support of tech transfer and validation
• Drive batch execution activities, including engineering, PPQ, and validation batches
• Develop and own the validation strategy, providing technical content and direction to supporting teams
• Provide technical guidance and source content to document writers for protocols, reports, and supporting documentation
• Engage directly with internal stakeholders and external clients to align on scope, timelines, and execution strategy
• Serve as the technical lead and point of accountability for fill/finish tech transfer success