Process Engineer

Pinnaql, Inc.; Raleigh (NC); Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

GMP compliance

Root cause analysis

Technical writing

Cross-functional collaboration

Process optimization

CAPA

Change control

Engineering documentation

Problem solving

Data analysis

Educación

Bachelor’s degree in Chemical Engineering

Bachelor’s degree in Mechanical Engineering

Bachelor’s degree in Industrial Engineering

Bachelor’s degree in Bioengineering

Herramientas

Automation & process control systems

Descripción del empleo

Current job opportunities are posted here as they become available.

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking an experienced Process Engineer to provide technical engineering support within a regulated pharmaceutical/biotechnology manufacturing environment. The Process Engineer will work closely with Engineering, Manufacturing, Quality, Validation, Maintenance, and other cross-functional teams to support process performance, equipment and system improvements, troubleshooting, capital projects, and continuous improvement initiatives. The ideal candidate is a hands-on engineer with strong technical problem-solving skills, experience working in GMP-regulated manufacturing environments, and the ability to independently manage engineering activities from problem identification through implementation and closure.

Description

• 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.

Qualifications

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Industrial Engineering, Bioengineering, or a related engineering discipline.
• Relevant process engineering experience within the pharmaceutical, biotechnology, medical device, or regulated manufacturing industry.
• 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 effectively 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.

Key Competencies: Process Engineering | Manufacturing Support | Troubleshooting | Root Cause Analysis | Process Optimization | Equipment & Systems | Technical Documentation | Change Control | CAPA | GMP Compliance | Capital Projects | CQV Support | Cross-Functional Collaboration | Continuous Improvement

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.