Senior Master Manufacturing Technician, Filling Operations

About the role

Roche/Genentech is building a new $2B drug product manufacturing facility in Holly Springs, North Carolina, focused on cardiovascular, renal and metabolism medicines. The Senior Master Manufacturing Technician supports the design, qualification, startup and registration of the high-volume filling lines, works with the User Team and partners with Engineering, Quality, Supply Chain, Regulatory and other groups. After go-live, the role moves into routine filling operations under cGMP, PQS and safety standards.

Key responsibilities

• Provide hands-on technical input and training on complex process and equipment technologies, including training materials for new hires and coaching less experienced colleagues.
• Support SOP authoring for new equipment, factory and site acceptance testing, equipment qualification (e.g. smoke studies) and process validation.
• Support the site's media fill program and give end-user feedback for the MES program.
• Serve as subject matter expert for regulatory inspections.
• Independently set up high-speed fill lines in an isolator environment, run environmental monitoring, intervene on breakdowns and resolve discrepancies and investigations.
• Complete and review process documentation, support training and departmental metrics reporting, and take part in safety inspections and project meetings.
• Train team members in good aseptic technique in clean rooms and isolators, and direct and coordinate daily team activities.

Required profile

• Minimum of high school and 9+ years of production experience, or an AA degree and 7+ years of technical experience in pharma, supply chain or manufacturing.
• Recognized as a subject matter expert for filling operations.
• Strong understanding of aseptic principles and proven ability to mentor others through new processes.
• Highly skilled at setting up and running fill lines in an isolator environment.

Required skills

• Proficient knowledge of SAP or ERP systems.
• Proficiency in a digital environment such as MES and Tulip is preferred.
• Bachelor's degree in science, manufacturing or engineering preferred.

What we offer

• Salary range of $61,600 - $114,400 in North Carolina, depending on experience and qualifications.
• A discretionary annual bonus may be available.
• Relocation benefits are available.
• The role is full-time and onsite, initially at the project office then at the site; travel of up to 30% is expected during the project phase, and overtime and schedule changes may be required.