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
