Master Manufacturing Technician, Inspection

In partnership with the Engineering and the start-up project (user) team, you will partner and collaborate with our partner organizations (Engineering and MSAT, Quality, Supply Chain, Technical Development, Regulatory, CMO, Strategy) to provide input as the end-user for activities related to design and start-up a new Drug Product Fill and Finish facility. This role specifically is about the design, qualification, start-up and registration of the facility's high volume automated visual inspection lines.

You will provide knowledge and training on complex process and equipment technologies to all required partners. You will provide training materials and training for people joining the organization. You will act as a coach for colleagues with less experience and help them develop skills/expertise. You will support authoring of standard operating procedures for new equipment. You will support acceptance testing to ensure that equipment is suitable for end-user execution.

Following go-live of the facility, you will transition into a routine position in the site and will extend into daily operation responsibilities. During the operational phase, you will be responsible for the visual inspection process following cGMP, PQS and Safety standards while maintaining a teamwork attitude to effectively manage production needs and meet the production schedule. The visual inspection process is inclusive of high speed automated visual inspection, manual inspection, inspection kit management, and the processes associated with operating this equipment.

The Master Inspection Technician role will be expected to bring technical expertise in one or more GMP systems, a detailed process understanding of the function and good people skills across the organization.

Responsibilities

• Master the daily operation, setup, and troubleshooting of high-speed Automated Visual Inspection (AVI) machines and secondary Visual Robotics units in a high-volume manufacturing setting.
• Perform manual visual inspections of filled drug products, classifying defects to ensure compliance with cGMP standards.
• Maintain, audit, and re-certify operational and qualification defect kits required for daily machine challenges, routine operation, and validation activities.
• Identify and resolve discrepancies, contribute to investigations, troubleshoot technical issues, and address system gaps.
• Manage material staging and movement for inspection lines to maintain continuous operational flow and consistently meet production schedules.
• Complete and review process-related documentation, communicate effectively with teams, and support training activities and departmental metrics reporting.
• Participate in safety inspections, scheduling meetings, project discussions, and other assigned tasks to maintain compliance and efficiency.
• Leverage strong interpersonal skills to train and mentor junior technicians, support onboarding, and drive departmental metrics.

Qualifications

You possess a minimum of High School and 7+ related year production experience and/or AA degree and 5+ years technical related experience in the pharma industry, supply chain management or in manufacturing. You have proficient knowledge and experience of SAP or ERP system.

Preferred qualifications: You possess a Bachelor's Degree in science, manufacturing or engineering. You have experience with high volume, low cost, drug product manufacturing and or supply chain.

Work Environment/Physical Demands/Safety Considerations

This role requires you to be onsite full time, initially at the Genentech project office before transitioning on-site once the site buildings are built and equipment delivered. Travel of up to 30% of the time is expected during the project phase to support facility acceptance testing. The environment requires gowning, gloves, steel toe boots and safety glasses (as required). Ability to work in controlled environments, as required. Candidates must be flexible to work overtime and adjust working schedule beyond normal work week. Work schedule may be subject to change based on the phase of the project and/or commercial demand. Ability to perform computer work and RF equipment, as required. Standing and Sitting is required for extended periods of time. Must be able to perform repetitive manufacturing work for extended periods of time. Must be able to perform visual inspection for extended periods of time. Must be able to lift 40lbs, push/pull >75lbs of force.