Master Manufacturing Technician, Autoinjector Assembly

RocheHolly Springs, NC
Onsite

About The Position

Welcome to Holly Springs, North Carolina— home to Roche/Genentech's largest-ever investment: a $2B greenfield start-up where next-generation technology, high-performing teams and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing. The facility's core is defined by Innovation - leveraging advanced automation, robotics, digital tools, real-time data analytics, and simple, streamlined processes to produce the highest quality medicines. This plant meets today’s demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines and is scalable to grow with the portfolio, which focuses on next-generation metabolic medicines specifically targeting the global obesity epidemic and Type 2 diabetes. This is a fast-paced, entrepreneurial environment with a high-level of accountability, with planned launch in 2028. Are you a problem-solver and change-agent who thrives in a Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to launch a state-of-the-art facility from the ground-up and shape the culture of our organization for the next generation. Join us in Holly Springs, where you won't just build a plant—you will build the future of medicine. The Opportunity: We're seeking a Master Manufacturing Technician to support the process design, qualification, startup and registration of our high volume autoinjector assembly lines at our state of the art facility. In this exciting role, you will support the User Team and will provide hands-on technical input for the new large volume manufacturing facility in Holly Springs. 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 autoinjector assembly 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 assembly of autoinjectors following cGMP, PQS and Safety standards while maintaining a teamwork attitude to effectively manage production needs and meet the production schedule. The Master Assembly 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. The successful candidate will need to demonstrate the following traits: Perform visual and dimensional inspections of autoinjector components and COA-released materials, ensuring compliance with quality standards. Identify and resolve discrepancies, contribute to investigations, troubleshoot technical issues, and address system gaps. Execute autoinjector tasks like device insertion, labeling and cap insertion, along with receiving and delivering materials, while focusing on quality and efficiency. 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.

Requirements

  • 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.
  • Proficient knowledge and experience of SAP or ERP system

Nice To Haves

  • Bachelor's Degree in science, manufacturing or engineering.
  • Experience with drug product manufacturing and or supply chain.

Responsibilities

  • Perform visual and dimensional inspections of autoinjector components and COA-released materials, ensuring compliance with quality standards.
  • Identify and resolve discrepancies, contribute to investigations, troubleshoot technical issues, and address system gaps.
  • Execute autoinjector tasks like device insertion, labeling and cap insertion, along with receiving and delivering materials, while focusing on quality and efficiency.
  • 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.
  • Provide knowledge and training on complex process and equipment technologies to all required partners.
  • Provide training materials and training for people joining the organization.
  • Act as a coach for colleagues with less experience and help them develop skills/expertise.
  • Support authoring of standard operating procedures for new equipment.
  • Support acceptance testing to ensure that equipment is suitable for end-user execution.
  • Responsible for the assembly of autoinjectors following cGMP, PQS and Safety standards while maintaining a teamwork attitude to effectively manage production needs and meet the production schedule.

Benefits

  • Relocation benefits are available for this job posting.
  • A discretionary annual bonus may be available based on individual and Company performance.
  • This position also qualifies for the benefits detailed at the link provided below.
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