GMP Process Engineer: Troubleshooting, Validation & CapEx

Veg Group; Durham (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG) seeks an experienced Process Engineer to deliver technical support in a regulated pharma/biotech environment. You will collaborate with Engineering, Manufacturing, Quality, and Validation to improve process performance, equipment, and system effectiveness.

The ideal candidate has hands-on GMP manufacturing experience, can manage activities from problem identification through execution, and excels in technical documentation and problem-solving.

Qualifications

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Industrial Engineering, Bioengineering, or related discipline.
• 5+ years of process or manufacturing engineering experience in pharmaceutical/biotech industries.
• Experience with GMP, change control, deviations, CAPA, and engineering documentation practices.
• Experience supporting capital projects and equipment/system lifecycle activities.
• Strong technical writing and communication skills.
• Ability to work independently while collaborating with multidisciplinary teams.

Responsibilities

• Provide day-to-day process engineering support to manufacturing and engineering operations.
• Evaluate process performance and identify opportunities to improve reliability, efficiency, capacity, quality, and operational performance.
• Lead or support troubleshooting and root-cause investigations related to manufacturing processes, equipment, and systems.
• Develop and implement engineering solutions to address process and equipment issues.
• Support capital projects, equipment upgrades, system modifications, and process improvement initiatives.
• Develop and review technical documentation including engineering assessments, specifications, protocols, reports, procedures, and change-control documentation.
• Coordinate engineering activities with Manufacturing, Quality, Validation, Automation, Maintenance, and other technical groups.
• Support commissioning, qualification, validation, startup, and turnover activities as required.
• Participate in change controls, deviations, investigations, CAPAs, and risk assessments from an engineering perspective.
• Analyze process and equipment data to identify trends, recurring issues, and improvement opportunities.
• Provide technical recommendations and support the development of corrective and preventive solutions.
• Coordinate activities with vendors, contractors, and equipment suppliers when required.
• Ensure engineering activities are performed in accordance with GMP requirements, engineering standards, procedures, and safety expectations.
• Maintain clear documentation and communicate project status, technical issues, risks, and recommendations to stakeholders.
• Support continuous improvement and standardization initiatives within the Engineering organization.

Skills

Process engineering

GMP knowledge

Root cause analysis

Change control

CAPA

Technical documentation

Cross-functional collaboration

Capital projects

CQV support

Education

Bachelor’s degree in Chemical/Mechanical/Industrial/Bioengineering or related field

Tools

Automation systems

Job description

Validation & Engineering Group, Inc. (V&EG) seeks an experienced Process Engineer to deliver technical support in a regulated pharma/biotech environment. You will collaborate with Engineering, Manufacturing, Quality, and Validation to improve process performance, equipment, and system effectiveness.

The ideal candidate has hands-on GMP manufacturing experience, can manage activities from problem identification through execution, and excels in technical documentation and problem-solving.