Senior Manufacturing Engineer

Manufacturing Engineering Manager

• Minimum of 3+ years of experience in a pharmaceutical manufacturing environment (required)
• Hands-on experience with injection molding processes in a manufacturing setting (required)

Position Summary

The Manufacturing Engineering Manager is responsible for leading and developing the manufacturing engineering team while driving continuous improvement across production processes within a regulated pharmaceutical manufacturing environment. This role ensures efficient, safe, and high-quality manufacturing operations through process optimization, problem-solving, and cross-functional collaboration.

Key Responsibilities

• Lead, manage, and mentor the Manufacturing Engineering team, including performance management and annual reviews
• Plan, prioritize, and assign engineering activities to support production and business objectives
• Conduct risk and opportunity assessments and implement appropriate mitigation or improvement actions
• Lead complex investigations, including root cause analysis and implementation of corrective and preventive actions (CAPA)
• Oversee production-related investigations, including quality deviations and customer complaints, and approve associated reports
• Drive Operational Excellence (OpEx) initiatives to improve efficiency, reduce waste, and optimize processes
• Design, develop, and optimize manufacturing workflows, systems, and resource utilization, with a focus on injection molding processes
• Ensure creation, maintenance, and compliance of manufacturing process documentation in accordance with pharmaceutical regulatory standards (e.g., GMP)
• Support the implementation and startup of new production systems and equipment, including injection molding technologies
• Initiate and manage change control processes within the department
• Coordinate validation and Design of Experiments (DOE) activities in a regulated environment
• Resolve production issues, delays, and bottlenecks in a timely manner
• Ensure compliance with all safety, health, environmental, and pharmaceutical regulatory requirements
• Identify and implement opportunities to improve safety, quality, and cost performance
• Support continuous development of production processes, systems, and personnel
• Stay current with industry trends, emerging technologies, and supplier capabilities, particularly in injection molding and pharmaceutical manufacturing
• Oversee training, qualification, and development of departmental personnel
• Perform other duties as assigned

Qualifications & Experience

• Bachelor’s degree in Engineering or a related field
• Minimum of 3+ years of experience in a pharmaceutical manufacturing environment (required)
• Hands-on experience with injection molding processes in a manufacturing setting (required)
• Strong knowledge of manufacturing processes, including high-throughput automated assembly and injection molding
• Experience working in a regulated environment with understanding of GMP and validation requirements
• Ability to interpret blueprints and working knowledge of pneumatic, hydraulic, electrical, mechanical, and basic programming systems
• Demonstrated commitment to health, safety, environmental, and regulatory compliance standards
• Proven problem-solving and analytical skills with the ability to troubleshoot complex production issues
• Strong communication and interpersonal skills
• Experience in project management and leading cross-functional teams
• Proven leadership and team management capabilities