Process Engineer

Job Title: Process Engineer

Location: Wilson, NC

Job Summary:

We are seeking an experienced GMP Process Engineer to support the design, installation, commissioning, and qualification of process equipment for plant operations. This role will focus on both upstream and downstream systems, including stainless steel vessels, SCADA systems, and cold room freezers. The successful candidate will ensure compliance with GMP and industry standards, working across departments to ensure smooth operations.

Key Responsibilities:

• Provide technical support for GMP process equipment, including both upstream and downstream systems.
• Oversee the installation, commissioning, and qualification of process equipment.
• Ensure compliance with GMP, regulatory, and safety standards throughout the project lifecycle.
• Collaborate with cross-functional teams, including engineering, quality, and operations, to support project success.
• Troubleshoot, optimize, and validate process equipment.
• Develop and maintain detailed documentation for equipment qualification and validation.

Qualifications & Skills:

• 4-8 years of experience in process engineering within a GMP-regulated environment.
• Hands-on experience with stainless steel vessels, SCADA systems, cold room freezers, and process equipment.
• Strong understanding of equipment qualification (IQ/OQ/PQ) and commissioning.
• Ability to work effectively in a fast-paced, collaborative environment.
• Excellent problem-solving and technical troubleshooting skills.
• Strong written and verbal communication skills.

Preferred Qualifications:

• Experience in biopharmaceutical or pharmaceutical manufacturing.
• Knowledge of automation and control systems.
• Familiarity with regulatory requirements such as FDA, EMA, and cGMP.
• This position offers an exciting opportunity to contribute to high-level operations and ensure compliance with GMP standards within a dynamic team environment.