Senior Master Filling Technician — Aseptic GMP Startup Lead

Genentech, Inc.; North Carolina; On-site; USD 62,000 - 114,000; Full time

Benefits offered by this job

Relocation benefits

Job summary

Genentech, Inc. in North Carolina seeks a Senior Master Manufacturing Technician to support design, qualification, startup, and registration of high-volume filling lines at a state-of-the-art facility in Holly Springs.

You will work with Engineering, MSAT, Quality, and Regulatory teams to ensure end-user input for design and startup activities. The role emphasizes aseptic setup in isolator environments, training others, and contributing to SOPs, qualification, and MES program development while

Qualifications

• High School diploma and 9+ years production experience or AA degree with 7+ years technical experience.
• Subject Matter Expert for Filling operations.
• Strong understanding of aseptic principles.
• Proficient with SAP or ERP systems.
• Experience instructing and mentoring team members.
• Skilled at setting up and running fill lines in isolator environments.
• Proficient in digital environments (MES, Tulip).

Responsibilities

• Provide knowledge and training on complex process and equipment technologies to required partners.
• Create training materials and train new joiners; act as a coach.
• Support authoring of standard operating procedures for new equipment.
• Assist factory/site acceptance testing to ensure equipment suitability for end-user execution.
• Support equipment qualification and process validation activities.
• Contribute to the site’s media fill program.
• Provide end user feedback for MES program development.
• Serve as SME for regulatory inspections.
• Transition to routine operating duties post go-live and maintain cGMP standards.

Skills

Aseptic principles

SAP/ERP systems

Mentoring team members

Isolator operations

MES systems

Tulip

Education

Bachelor's Degree in science/manufacturing/engineering

AA degree

High School diploma

Tools

SAP

MES

Tulip

Job description

Genentech, Inc. in North Carolina seeks a Senior Master Manufacturing Technician to support design, qualification, startup, and registration of high-volume filling lines at a state-of-the-art facility in Holly Springs.

You will work with Engineering, MSAT, Quality, and Regulatory teams to ensure end-user input for design and startup activities. The role emphasizes aseptic setup in isolator environments, training others, and contributing to SOPs, qualification, and MES program development while