Senior Process Engineer - GMP Biotech & Pharma Manufacturing

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

Job summary

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks an experienced Process Engineer for a regulated pharma/biotech manufacturing environment in Raleigh, NC. You will support day-to-day processing, troubleshoot issues, and drive improvements across projects and equipment.

The role emphasizes independent management of engineering activities from problem identification through closure, collaboration with multiple teams, and compliance with GMP and change control practices.

Qualifications

• Bachelor’s degree in Chemical Engineering, Mechanical, Industrial, Bioengineering, or related engineering discipline.
• Relevant process engineering experience in pharmaceutical/biotech/regulatory manufacturing.
• Strong understanding of manufacturing processes, equipment, utilities, and engineering principles.
• Experience troubleshooting process and equipment 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.
• Ability to work independently while collaborating with multidisciplinary teams.
• Strong organizational skills to manage multiple activities and priorities.
• 5+ years in process/manufacturing engineering within pharma/biotech.
• Experience supporting biopharmaceutical manufacturing processes and equipment.
• Experience with commissioning, qualification, validation, and equipment startup.
• Familiarity with process optimization, characterization, troubleshooting, and RCA.
• Experience supporting capital projects and lifecycle activities.
• Working knowledge of automation and process control systems.
• Experience working in a highly regulated GMP 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 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, upgrades, system modifications, and process improvements.
• Develop and review technical documentation including assessments, specifications, protocols, reports, and change-control docs.
• Support equipment and process design reviews, evaluations, and implementations.
• Coordinate engineering activities with Manufacturing, Quality, Validation, Automation, Maintenance, and others.
• Support commissioning, qualification, validation, startup, and turnover activities as required.
• Participate in change controls, deviations, investigations, CAPAs, and risk assessments from engineering perspective.
• Analyze process and equipment data to identify trends and improvements.
• Provide technical recommendations and corrective/preventive solutions.
• Coordinate activities with vendors, contractors, and equipment suppliers when required.
• Ensure activities meet GMP requirements and safety expectations.
• Maintain documentation and communicate status, issues, risks, and recommendations to stakeholders.
• Support continuous improvement and standardization within Engineering.

Skills

GMP compliance

Root cause analysis

Technical writing

Cross-functional collaboration

Process optimization

CAPA

Change control

Engineering documentation

Problem solving

Data analysis

Education

Bachelor’s degree in Chemical Engineering

Bachelor’s degree in Mechanical Engineering

Bachelor’s degree in Industrial Engineering

Bachelor’s degree in Bioengineering

Tools

Automation & process control systems

Job description

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks an experienced Process Engineer for a regulated pharma/biotech manufacturing environment in Raleigh, NC. You will support day-to-day processing, troubleshoot issues, and drive improvements across projects and equipment.

The role emphasizes independent management of engineering activities from problem identification through closure, collaboration with multiple teams, and compliance with GMP and change control practices.