Process Engineer – CIP / GMP

Process Engineer – CIP / GMP

About the Role

We are seeking a Process Engineer to support a project in North Carolina . The role will focus on CIP (Clean-in-Place) shakedown, troubleshooting, cycle parameter development, cycle execution, and process performance .

The position may also involve functional supervision, coordination of technical staff, and collaboration with internal departments, clients, and vendors. Assignments are broad in scope and require the ability to exercise independent technical judgment.

Shift work is required.

Key Responsibilities

• Provide subject matter expertise for engineering, startup, commissioning, and CIP cycle development projects.
• Lead and coordinate technical staff in the execution of various engineering and process activities.
• Review engineering specifications to ensure compliance with applicable regulations, standards, and engineering requirements.
• Serve as a technical representative when consulting with clients and vendors regarding significant technical issues or project developments.
• Prepare periodic technical reports, records, and project documentation.
• Provide technical guidance and respond to process and engineering-related questions.
• Develop cleaning cycle strategies for a variety of pharmaceutical manufacturing equipment, including:
• Process vessels and process lines
• Chromatography skids and columns
• UF/DF skids
• Centrifuges
• Glassware and parts washers
• Portable processing equipment
• Perform batch record reviews, including verification of calibration status and in-process data.
• Perform piping design and flow calculations for CIP systems.
• Support troubleshooting and resolution of CIP system and process issues.
• Perform CIP shakedown activities, cycle runs, and parameter adjustments.
• Support commissioning activities and provide automation support for CIP systems, including PLC, SCADA, and DeltaV platforms.
• Collaborate with engineering, manufacturing, automation, quality, validation, clients, and vendors to resolve technical issues and support project objectives.

Required Qualifications

• Bachelor’s degree in Chemical Engineering or a related engineering discipline .
• Minimum of 5 years of pharmaceutical manufacturing or GMP-regulated industry experience .
• Hands-on experience with:
• CIP cycle development
• Cleaning validation
• Protocol development and execution
• Validation and cycle summary reports
• CIP shakedown and troubleshooting
• CIP parameter changes and optimization
• CIP cycle execution and performance evaluation
• Familiarity with plant control systems, including PLC, SCADA, and DeltaV .
• Experience or familiarity with engineering project management.
• Strong verbal and written communication skills.
• Strong analytical, troubleshooting, and problem-solving abilities.
• Proficiency with Microsoft Office and other standard engineering/computer applications.
• Ability to work effectively in a fast-paced, GMP-regulated manufacturing environment.
• Willingness and ability to work assigned shifts.