GMP Process Engineer - Pharma & Biotech Solutions

Pinnaql, Inc.; Durham (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks an experienced Process Engineer to provide technical support in a regulated pharmaceutical/biotechnology manufacturing environment.

The role focuses on process performance, equipment and system improvements, troubleshooting, capital projects, and continuous improvement across cross-functional teams. You will independently manage engineering activities from problem identification through implementation and closure, ensuring GMP requirements and

Qualifications

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Industrial Engineering, Bioengineering, or a related engineering discipline.
• Relevant process engineering experience within pharmaceutical/biotech/medical device or regulated manufacturing.
• Strong understanding of manufacturing processes, equipment, utilities, and engineering principles.
• Experience troubleshooting process and equipment-related issues in a manufacturing environment.
• Knowledge of GMP requirements, change control, deviations, CAPA, and engineering documentation practices.
• Experience supporting equipment modifications, process improvements, or capital projects.
• Ability to analyze technical data and translate findings into practical engineering solutions.
• Strong technical writing, documentation, and communication skills.
• Demonstrated ability to work independently while collaborating with multidisciplinary teams.
• Strong organizational skills with the ability to manage multiple activities and priorities.
• 5+ years of relevant process or manufacturing engineering experience within the pharmaceutical or biotechnology industry.
• Experience supporting biopharmaceutical manufacturing processes and equipment.
• Experience with commissioning, qualification, validation, and equipment startup.
• Familiarity with process optimization, process characterization, troubleshooting methodologies, and root-cause analysis.
• Experience supporting capital projects and equipment/system lifecycle activities.
• Working knowledge of automation and process control systems.
• Experience working in a highly regulated GMP manufacturing environment.

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.
• Support equipment and process design reviews, technical evaluations, and implementation activities.
• 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 applicable 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

GMP compliance

Root cause analysis

Technical documentation

Cross-functional collaboration

CAPA

Process optimization

CQV support

Change control

Capital projects

Validation

Education

Bachelor’s degree in Chemical/Mechanical/Industrial/Bioengineering

Job description

Validation & Engineering Group, Inc. seeks an experienced Process Engineer to provide technical support in a regulated pharmaceutical/biotechnology manufacturing environment.

The role focuses on process performance, equipment and system improvements, troubleshooting, capital projects, and continuous improvement across cross-functional teams. You will independently manage engineering activities from problem identification through implementation and closure, ensuring GMP requirements and