Manufacturing Engineer

Key Responsibilities

• Support daily manufacturing operations to ensure safe, efficient, and compliant production.
• Assist in monitoring and improving manufacturing processes to enhance productivity and product quality.
• Support equipment installation, qualification, troubleshooting, and maintenance activities.
• Affiliate with process validation, equipment qualification (IQ/OQ/PQ), and manufacturing documentation.
• Collaborate with Manufacturing, Production, Quality Assurance, Validation, Engineering, and Regulatory teams.
• Collect and analyze manufacturing data to identify process improvement opportunities.
• Affiliate with deviation investigations, CAPA activities, and change control documentation.
• Ensure compliance with GMP, cGMP, FDA regulations, ISO standards, and company quality procedures.
• Participate in Lean Manufacturing and continuous improvement initiatives.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, or a related engineering discipline.
• 0 1 year of experience through internships, co-op programs, academic projects, or entry-level roles in pharmaceutical, biotechnology, medical device, or regulated manufacturing environments.
• Basic understanding of manufacturing processes and engineering principles.
• Familiarity with GMP/cGMP, FDA regulations, ISO 13485, or regulated manufacturing practices is preferred.
• Basic knowledge of process validation, equipment qualification, and quality systems is a plus.
• Strong analytical, troubleshooting, and problem-solving skills.
• Excellent written and verbal communication skills.
• Ability to work effectively in a cross-functional team environment.
• Proficiency in Microsoft Office applications.
• Eagerness to learn and grow in a regulated manufacturing environment.