Technical Lead, Manufacturing Line & Process Excellence

Planet Pharma; San Diego, Los Angeles (CA, CA); On-site; USD 110,000 - 138,000; Full time

Benefits offered by this job

On-site

Job summary

Planet Pharma seeks a senior Manufacturing Engineering leader to drive safe, compliant, and efficient production operations in California. You will own process validation, equipment reliability, and continuous improvement initiatives supporting commercial production and new product introductions.

Collaborate across Operations, Quality, Regulatory Affairs, and R&D to ensure adherence to FDA QSR, ISO 13485, and company procedures.

Qualifications

• Requires a Bachelor's degree or higher with 7+ years of relevant experience.
• Experience with process validation, change control, and SPC techniques.
• Knowledge of FDA Quality System Regulations and ISO 13485 is preferred.
• Proficiency with Microsoft Office and document management systems.

Responsibilities

• Leads design and validation of manufacturing processes, layouts and equipment.
• Ensures production processes meet quality, safety, and regulatory standards.
• Drives process validation activities and equipment qualification.
• Collaborates with Operations, Quality, Regulatory, and R&D teams.
• Monitors production metrics (yield, throughput, capacity, OEE) and implements improvements.
• Mentors engineers and cross-functional teams.
• Oversees capital equipment projects and manufacturing scale-up.
• Supports NPI activities and technology transfer.

Skills

Process Validation

OEE analysis

Project management

Root Cause Analysis

Statistical Analysis

Education

Bachelor's degree in engineering

Tools

SAP

MES

AutoCAD

SolidWorks

Minitab

Job description

Planet Pharma seeks a senior Manufacturing Engineering leader to drive safe, compliant, and efficient production operations in California. You will own process validation, equipment reliability, and continuous improvement initiatives supporting commercial production and new product introductions.

Collaborate across Operations, Quality, Regulatory Affairs, and R&D to ensure adherence to FDA QSR, ISO 13485, and company procedures.