Senior Process Engineer

• ◆Provide continuous process engineering support for manufacturing and engineering operations.
• ◆Assess process performance and identify areas for improved reliability, efficiency, and capacity.
• ◆Lead troubleshooting efforts and root-cause investigations related to manufacturing processes, equipment, and systems.
• ◆Design and implement engineering solutions to resolve process and equipment challenges.
• ◆Assist with capital projects, upgrades, modifications, and initiatives focused on process improvement.
• ◆Create and evaluate technical documentation, including assessments, specifications, protocols, and change-control documents.
• ◆Participate in equipment and process design reviews, evaluations, and implementation processes.
• ◆Coordinate engineering efforts with cross-functional teams including Manufacturing, Quality, Validation, and Maintenance.
• ◆Support commissioning, qualification, validation, startup, and turnover activities as needed.
• ◆Engage in change controls, deviations, investigations, CAPAs, and risk assessments from an engineering viewpoint.
• ◆Analyze process and equipment data to uncover trends and opportunities for enhancement.
• ◆Offer technical guidance and aid in developing corrective and preventive measures.
• ◆Manage activities with vendors, contractors, and equipment suppliers as necessary.
• ◆Ensure engineering tasks align with GMP requirements, engineering standards, and safety protocols.
• ◆Deliver clear documentation and regularly update stakeholders on project status and technical concerns.
• ◆Promote continuous improvement and standardization within the Engineering team.

• ✓Bachelor's degree in Chemical, Mechanical, Industrial, Bioengineering, or a similar discipline.
• ✓5+ years of relevant process engineering experience in the pharmaceutical, biotechnology, medical device, or regulated manufacturing sectors.
• ✓Strong grasp of manufacturing processes, equipment, and engineering principles.
• ✓Proficient in trouble-shooting process and equipment issues within a manufacturing context.
• ✓In-depth knowledge of GMP guidelines, change control, deviations, CAPA, and engineering documentation standards.
• ✓Experience contributing to equipment modifications, process enhancements, and capital project support.
• ✓Ability to interpret technical data and convert findings into practical engineering solutions.
• ✓Excellent technical writing and communication skills.
• ✓A track record of working independently while effectively collaborating with diverse teams.
• ✓Exceptional organizational skills with the ability to manage multiple projects and priorities.
• ✓Experience in supporting biopharmaceutical manufacturing processes and equipment.
• ✓Familiarity with commissioning, qualification, validation, and equipment startups.
• ✓Understanding of process optimization, characterization, troubleshooting methods, and root-cause analysis.
• ✓Experience overseeing capital projects and equipment/system lifecycle management.
• ✓Basic knowledge of automation and process control systems.
• ✓Hands-on experience in a strictly 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. When you are empowered to excel at your work, innovative ideas flourish and real progress is achieved. This isn't merely a job - it's a chance to make a significant impact in healthcare and technology, accompanied by a committed and supportive team.

Ready to embark on a meaningful journey with us? We eagerly anticipate your application!