Technical Lead, Manufacturing Line

Technical Lead, Manufacturing Line

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 may include the following and other duties may be assigned.

• 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

• Equal Opportunity Employer

• We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

• Fraud Alert

• Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from a official Planet Pharma domain and not a domain with an alternative extension like .net, .org or .jobs.

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