Process Engineer

Katalyst-Healthcares-; Wilson (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

Creative Solutions Services, LLC is seeking an experienced Process Engineer to support the design, execution, and startup of a GMP large molecule biologics drug substance manufacturing facility in Wilson, NC. The role provides technical leadership for process systems, manufacturing equipment, utilities, facilities, automation, and operational readiness.

The ideal candidate will have 8+ years in GMP biopharma process/plant/manufacturing engineering, hands-on FAT/SAT experience, and a track record

Qualifications

• Minimum of 8 years of process engineering, plant engineering, or manufacturing engineering experience in GMP large molecule biologics facilities.
• Strong experience supporting GMP manufacturing facilities within pharmaceutical/biotech industries.
• Experience with equipment design, equipment specifications, and engineering requirements.
• Hands-on FAT and SAT execution experience.
• Experience supporting equipment installation, commissioning, startup, and operational readiness.
• Proven experience managing and coordinating equipment vendors.
• Experience with greenfield or brownfield GMP facility startup.
• Experience with process systems, automation, utilities, facilities, and manufacturing operations.
• Strong GMP regulatory knowledge and expectations.
• Experience supporting technology transfer and manufacturing projects.

Responsibilities

• Support greenfield and brownfield GMP manufacturing facility development and startup.
• Provide engineering support for technology transfer and new technology development projects.
• Ensure process designs and equipment solutions meet manufacturing requirements and plant practices.
• Collaborate with Technical Operations to align with standards and specifications.
• Translate business needs into practical engineering solutions.
• Lead cross-functional teams on projects, process improvements and initiatives.
• Identify and resolve technical, operational, and inter-functional issues.
• Collaborate with Manufacturing, Quality, Engineering and Operations to define project requirements and priorities.
• Ensure activities comply with GMP and regulatory requirements.
• Support project planning, execution, risk management, escalation and conflict resolution.
• Drive right-first-time execution, safe startup, and reliable manufacturing performance.
• Provide technical leadership and coordination across multiple project teams.
• Support innovative engineering and process technology solutions to improve performance.

Skills

Process engineering

GMP compliance

Project leadership

Regulatory knowledge

Tech transfer

Vendor coordination

Startup/ commissioning

Job description

Summary :

We are seeking an experienced Process Engineer to support the design, execution, and startup of a GMP large molecule biologics drug substance manufacturing facility in Wilson, North Carolina. The engineer will provide technical leadership for process systems, manufacturing equipment, utilities, facilities, automation, and operational readiness.

Roles and Responsibilities :

• Support greenfield and brownfield GMP manufacturing facility development and startup.


• Provide engineering support for technology transfer and new technology development projects.


• Ensure process designs and equipment solutions are aligned with manufacturing requirements and plant operating practices.


• Collaborate with Technical Operations to ensure alignment with technology standards and engineering specifications.


• Translate business needs, manufacturing requirements, engineering inputs, and technology requirements into practical engineering solutions.


• Lead cross-functional teams on engineering projects, process improvements, and manufacturing initiatives.


• Identify, assess, and resolve technical, operational, and inter-functional issues.


• Collaborate with Manufacturing, Quality, Engineering, Operations, and other stakeholders to define project requirements and priorities.


• Ensure engineering activities comply with GMP and applicable regulatory requirements.


• Support project planning, execution, risk management, issue escalation, and conflict resolution.


• Drive right-first-time execution, safe startup, and reliable manufacturing performance.


• Provide technical leadership, communication, and coordination across multiple project teams.


• Support innovative engineering and process technology solutions to improve manufacturing performance and project execution.

Education & Experience :

• Minimum of 8 years of process engineering, plant engineering, or manufacturing engineering experience in GMP large molecule biologics facilities.


• Strong experience supporting GMP manufacturing facilities within the pharmaceutical or biotechnology industry.


• Experience with equipment design, equipment specifications, and engineering requirements.


• Hands-on experience with FAT and SAT execution.


• Experience supporting equipment installation, commissioning, startup, and operational readiness.


• Proven experience managing and coordinating equipment vendors.


• Experience with greenfield or brownfield GMP manufacturing facility startup.


• Experience with process systems, automation, utilities, facilities, and manufacturing operations.


• Strong understanding of GMP requirements and regulatory expectations.


• Experience supporting technology transfer and manufacturing projects.


• Strong technical background in process and manufacturing engineering.