Senior Filling Technician – Isolator GMP Expert

F. Hoffmann-La Roche AG; Holly Springs (NC); On-site; USD 62,000 - 114,000; Full time

Benefits offered by this job

Relocation benefits

Job summary

F. Hoffmann-La Roche AG in North Carolina is launching a state-of-the-art high-volume Drug Product filling facility. The Senior Master Manufacturing Technician will help design, qualify, start-up and register the lines, training teams and ensuring cGMP standards.

You will work with Engineering, MSAT, Quality and Regulatory groups, mentoring colleagues and contributing to the MES and digital tooling programs while supporting safety and efficiency in a fast-paced environment.

Qualifications

• Minimum High School with 9+ years production experience and/or AA degree with 7+ years technical pharma experience.
• Recognized as a Subject Matter Expert for filling operations.
• Strong understanding of aseptic principles.
• Proficient knowledge of SAP or ERP systems.
• Proven track record mentoring team members through new processes.
• Skilled at setting up and running fill lines in isolator environments.
• Proficient in working in a digital environment (MES, Tulip, etc.).

Responsibilities

• Provide knowledge and training on complex process and equipment technologies to partners.
• Create training materials and train new joiners; act as a coach.
• Assist in authoring SOPs for new equipment.
• Support factory/site acceptance testing to ensure equipment suitability.
• Support equipment qualification and process validation activities.
• Contribute to the site media fill program creation.
• Provide end-user feedback for MES program development.
• Serve as SME for regulatory inspections.
• During operations, manage aseptic fill tasks in accordance with cGMP and PQS.

Skills

SME for Filling operations

Aseptic principles

SAP/ERP proficiency

Training/mentoring

Isolator environment operations

Education

High School + 9+ years experience

AA degree

Bachelor's in science/manufacturing/engineering

Tools

SAP

MES

Tulip

Job description

F. Hoffmann-La Roche AG in North Carolina is launching a state-of-the-art high-volume Drug Product filling facility. The Senior Master Manufacturing Technician will help design, qualify, start-up and register the lines, training teams and ensuring cGMP standards.

You will work with Engineering, MSAT, Quality and Regulatory groups, mentoring colleagues and contributing to the MES and digital tooling programs while supporting safety and efficiency in a fast-paced environment.