Process Engineer (Downstream) (Holly Springs)

Our client is seeking a number of Process Engineers to join their team in the Raleigh-Durham area. As the site prepares for operations this team is supporting the final CQV activities and manufacturing operations startup activities centered around the following areas: Buffer Prep and Buffer Hold unit operations of Mixing, Transfer and Hold of Buffers, initial purification unit operations, and final purification. Secondary responsibility includes supporting commercial operations, technology transfers, and small capital projects.

The Process Engineers provides engineering guidance to support capital projects, technology transfer, and manufacturing operations to ensure compliance with all safety, regulatory, and engineering requirements. This role adheres to product and customer requirements and work towards optimizing plant efficiency and profitability.

Responsibilities:

Develop and align basic plans and provides mitigations, as needed

Provide direction to detailed design activities in partnership with the EPCM provider

Writing User Requirements Specifications (URSs)

Reviewing piping and instrumentation diagrams (P&IDs) and other process design documents

Supporting Commissioning Qualification and Validation (CQV), and start-up activities

Perform system impact assessments and quality risk assessments for process equipment

Perform technology transfer (TT) activities related to process equipment

Support execution of Good Manufacturing Practices (GMP) runs

Provides technical support for root cause analysis (RCA) and process deviation investigations

Leads or assists with deviations, change controls, and corrective and preventive action (CAPA) closures

Makes decisions regarding technical risk assessments for new manufacturing equipment

Provides on-floor manufacturing support for equipment issues

Must Haves:

• Minimum 5+ years of Process Engineering experience
• Minimum 2+ years supporting downstream processes and equipment
• Prior experience working in a cGMP environment or other highly regulated industry