Lead Manufacturing Technician (2nd shift)

About the role

Based in San Clemente, CA, the Lead Manufacturing Technician is responsible for completing scheduled production and managing preventative maintenance. This role ensures proper documentation (cGMP and GDP), opens/closes jobs in the MRP system, and provides feedback to Management and Engineering. The position also involves preparing components, building assemblies, and bulk drug formulations, all performed under good documentation practices (GDP) in compliance with current good manufacturing practices (cGMPs) and quality system regulation (QSR) medical device GMP requirements.

Responsibilities

• Manage the operation and project schedules, adjusting resources as needed.
• Supervise production technician(s) to optimize quality and output.
• Perform all activities outlined for a Manufacturing Technician as required.
• Verify all documentation is followed and completed accurately (cGMP, QSR, and GDP).
• Manage Oracle to open and close jobs.
• Handle inventory requests and reconciliation for accuracy.
• Revise documentation to ensure accuracy and compliance.
• Communicate feedback to Engineering on Non-Standard Build Requests, Validation builds, Clinical builds, etc.
• Perform filing, capping, and crimping operations.
• Execute packaging and labeling operations.
• Conduct sampling and visual inspections.
• Document and input data into materials requirement planning (MRP), Batch Records (BRs), and Device History Records (DHR).
• Track clean room, environmental chambers, and equipment preventive maintenance (PMs).

Requirements

• Industry experience in medical device, pharmaceutical, and/or biotechnology.
• 8–10 years of experience with a high school diploma.
• 6–8 years of experience with an associate degree in science or engineering.
• 4–6 years of experience with a bachelor’s degree in science or engineering.
• Experience working in and maintaining a clean room in accordance with GDP, cGMPs, and QSR standards (highly desirable).