Technical Lead, Manufacturing Line

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

Description:
Provides technical leadership for production line to ensure safe, compliant, efficient, and reliable manufacturing operations. This role serves as the primary engineering lead responsible for process validations, process performance, equipment reliability, product quality, capacity expansion, and continuous improvement initiatives. They collaborate cross-functionally with Operations, Quality, Supply Chain, Research & Development, Regulatory Affairs, and Manufacturing Engineering teams to support commercial production, new product introductions and operational excellence objectives.

Responsibilities

• Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
• Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
• Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
• Adapts machine or equipment design to factory and production conditions.
• May 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 manufacturing processes that are applicable to statistical process control, and may develop those techniques.
• Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Ensures processes and procedures are in compliance with regulations.
• Lead process validations, equipment qualifications, and implementation of manufacturing changes in compliance with regulatory requirements.
• Partner with Operations and Quality teams to ensure compliance with FDA Quality System Regulations, ISO 13485 requirements, and company procedures.
• Identify and mitigate technical risks impacting safety, quality, delivery, or manufacturing continuity.
• Support new product introduction (NPI) activities, including process development, line readiness, technology transfer, and manufacturing scale-up.
• Provide technical oversight for capital equipment projects, automation initiatives, and facility upgrades.
• Analyze and report manufacturing performance metrics like LBM, yield, capacity and develop action plans to improve throughput, efficiency, and overall equipment effectiveness (OEE).
• Serve as the primary technical escalation point and owner for technical strategy, operational performance, product launch and hypercare of the manufacturing line.
• Mentor and guide manufacturing engineers, process engineers, and cross-functional team members

Requirements

• Requires mastery of a specialty area and full knowledge of industry practices and knowledge of project management, typically obtained through advanced education combined with experience. 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 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.
• Semi - automated manufacturing equipment and assembly systems, PLC-controlled equipment and machine interfaces, vision inspection systems, welding plastic injection molded parts, OEE analysis
• Process Validation, Test Method Validation, Change Control management, Statistical Analysis, Root Cause Analysis, Capacity Planning, Yield Improvement, Scrap Reduction
• Technical decision making, project planning and execution to goals, resource prioritization
• Microsoft Office, SAP, MES, AutoCAD, SolidWorks, Minitab, Document Management System

Fully onsite in San Diego or Calabasas, CA area, pay $80-100/hr based on experience level