Novozen Healthcare LLC
Job Title:
Senior Manufacturing Engineer About the Role As a Senior Manufacturing Engineer, you will play a critical role in shaping the future of diagnostic production processes. You’ll define equipment specifications, lead automation initiatives, and drive projects that reduce downtime, improve yields, and ensure compliance with cGMP standards—directly impacting product quality and operational excellence. Key Responsibilities Define equipment specifications and lead automation projects to optimize manufacturing processes. Plan and manage filling and packaging projects, ensuring alignment with business objectives and regulatory requirements. Develop user requirements, bid packages, and execute validation protocols (IQ/OQ/PQ). Improve equipment uptime, repair efficiency, and overall system reliability. Create and maintain SOPs, technical records, and equipment specifications to support new product launches. Lead cross-functional teams to successfully deliver complex projects on time. Ensure compliance with cGMP, FDA, and ISO standards in all manufacturing activities. Identify, recommend, and implement process improvements to enhance quality, efficiency, and scalability. Provide technical expertise in packaging, microdispensing, automation systems, and material science. What the Client is Looking For Bachelor’s degree in Mechanical Engineering or a related field. Proven experience in cGMP-regulated manufacturing environments. Hands-on expertise with automated filling and packaging systems. Strong knowledge of validation processes (IQ/OQ/PQ) and equipment qualification. Familiarity with FDA and ISO compliance requirements. Demonstrated ability to lead cross-functional project teams. Strong problem-solving skills and a focus on continuous improvement. Excellent documentation skills (SOPs, specifications, technical protocols). Preferred: background in material science, microdispensing, or injection molding. Why Join? Influence the design, scale-up, and optimization of next-generation manufacturing equipment. Work on cutting-edge automation, microdispensing, and packaging systems. Be part of a collaborative environment driving innovation, quality, and operational excellence. Opportunity to make a direct impact on products that improve patient outcomes. Seniority level:
Mid-Senior level Employment type:
Contract Job function:
Science, Engineering, and Manufacturing Industries:
Pharmaceutical Manufacturing and Biotechnology Research Novozen Healthcare LLC is an equal opportunities employer and welcomes applications from diverse candidates.
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Senior Manufacturing Engineer About the Role As a Senior Manufacturing Engineer, you will play a critical role in shaping the future of diagnostic production processes. You’ll define equipment specifications, lead automation initiatives, and drive projects that reduce downtime, improve yields, and ensure compliance with cGMP standards—directly impacting product quality and operational excellence. Key Responsibilities Define equipment specifications and lead automation projects to optimize manufacturing processes. Plan and manage filling and packaging projects, ensuring alignment with business objectives and regulatory requirements. Develop user requirements, bid packages, and execute validation protocols (IQ/OQ/PQ). Improve equipment uptime, repair efficiency, and overall system reliability. Create and maintain SOPs, technical records, and equipment specifications to support new product launches. Lead cross-functional teams to successfully deliver complex projects on time. Ensure compliance with cGMP, FDA, and ISO standards in all manufacturing activities. Identify, recommend, and implement process improvements to enhance quality, efficiency, and scalability. Provide technical expertise in packaging, microdispensing, automation systems, and material science. What the Client is Looking For Bachelor’s degree in Mechanical Engineering or a related field. Proven experience in cGMP-regulated manufacturing environments. Hands-on expertise with automated filling and packaging systems. Strong knowledge of validation processes (IQ/OQ/PQ) and equipment qualification. Familiarity with FDA and ISO compliance requirements. Demonstrated ability to lead cross-functional project teams. Strong problem-solving skills and a focus on continuous improvement. Excellent documentation skills (SOPs, specifications, technical protocols). Preferred: background in material science, microdispensing, or injection molding. Why Join? Influence the design, scale-up, and optimization of next-generation manufacturing equipment. Work on cutting-edge automation, microdispensing, and packaging systems. Be part of a collaborative environment driving innovation, quality, and operational excellence. Opportunity to make a direct impact on products that improve patient outcomes. Seniority level:
Mid-Senior level Employment type:
Contract Job function:
Science, Engineering, and Manufacturing Industries:
Pharmaceutical Manufacturing and Biotechnology Research Novozen Healthcare LLC is an equal opportunities employer and welcomes applications from diverse candidates.
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