Sr Manufacturing Engineer

Planet Pharma; San Diego, Los Angeles (CA, CA); On-site; USD 83,000 - 110,000; Full time

Job summary

Planet Pharma in San Diego, CA seeks a Senior Manufacturing Engineer to own manufacturing processes, validations, equipment readiness, capacity expansion, and continuous improvement. You will drive development, validation, implementation, and optimization to meet quality and regulatory goals.

Responsibilities include IQ/OQ/PQ execution, design support, automation initiatives, and leading root-cause investigations. Travel up to 50% is expected; onsite work is required.

Qualifications

• Advanced knowledge of manufacturing processes and validation.
• Experience with medical device manufacturing operations.
• Strong understanding of process control methodologies.

Responsibilities

• Own manufacturing processes, validations, and equipment readiness.
• Lead IQ, OQ, and PQ protocols and test method development.
• Drive yield, throughput, and capacity improvements.
• Partner with suppliers and internal teams to improve reliability.

Skills

Process validation

Equipment qualification

Statistical analysis

Project management

Travel up to 50%

Education

Bachelor's degree or higher

Job description

Job Description:

The Senior Manufacturing Engineer serves as the technical process owner responsible for manufacturing process validations, performance, equipment readiness, capacity expansion, and continuous improvement activities to meet the yield, capacity, throughput, reliability and quality goals. This role drives the development, validation, implementation, and optimization of manufacturing processes to ensure product quality, regulatory compliance, operational excellence, and successful commercialization. This role partners closely with internal and external stakeholder teams to support production objectives, resolve technical challenges, and execute strategic initiatives that improve manufacturing capability, efficiency, and reliability.

• Designs manufacturing processes, procedures and production layouts for semi automation equipment installation, processing and material handling.
• Adapts machine or equipment design to factory and production conditions, incorporate inspection and test requirements into the production plan.
• Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
• Develops and maintains manufacturing process specifications, work instructions, and engineering documentation
• Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Develop and execute equipment and process validation activities, including IQ, OQ, and PQ protocols and test method development and validation
• Supports automation initiatives and advanced manufacturing technologies
• Serve as the primary technical escalation point for complex manufacturing and quality issues.
• Lead root cause investigations utilizing structured problem-solving tools such as 5 Why, Fishbone Analysis, and Statistical Analysis.
• Lead initiatives to improve yield, reduce scrap, increase throughput, and optimize labor utilization.
• Partner with equipment suppliers and internal stakeholders to improve equipment capability and reliability.
• Develop manufacturing strategies for commercial production ramp-up, identify and eliminate bottlenecks impacting manufacturing performance.
• Ensures processes and procedures are in compliance with FDA Quality System Regulations, ISO 13485 requirements, and company procedures

Requirements:

Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience. Experience supporting medical device manufacturing operations. Strong understanding of manufacturing process validation and equipment qualification. Experience with statistical analysis and process control methodologies. Able to travel ~50%

Fully onsite, pay ~60-80/hr based on experience