Senior Master Manufacturing Technician, Filling Operations
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 Senior Master Manufacturing Technician to support the process design, qualification, startup and registration of our high volume filling 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 filling 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 factory and site acceptance testing to ensure that equipment is suitable for end-user execution. You will support equipment qualification (e.g. smoke studies) and process validation activities. You will support the creation of the site’s media fill program. You will provide end user feedback for the creation of the MES program. Serve as an SME for regulatory inspections. 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 filling operations following cGMP, PQS and Safety standards while maintaining a teamwork attitude to effectively manage production needs and meet the production schedule. The Senior Master Filling 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: You will independently perform aseptic set up of the high speed fill lines within an isolator environment. You will identify and resolve discrepancies, contribute to investigations, troubleshoot technical issues, and address system gaps. You will execute filling tasks such as line set up, environmental monitoring, interventions, and system breakdown, all while focusing on quality and efficiency. You will complete and review process-related documentation, communicate effectively with teams, and support training activities and departmental metrics reporting. You will participate in safety inspections, scheduling meetings, project discussions, and other assigned tasks to maintain compliance and efficiency. You will demonstrate and train team members on good aseptic techniques within a clean room and isolator environment according to cGMP practices. You will direct, coordinate, and prioritize daily activities for the team in order to ensure objectives and performance indicators are met.
Requirements
- Minimum of High School and 9+ related year production experience and/or AA degree and 7+ years technical related experience in the pharma industry, supply chain management or in manufacturing.
- Recognized as a Subject Matter Expert (SME) for Filling operations.
- Strong understanding of aseptic principles.
- Proficient knowledge and experience of SAP or ERP systems.
- Proven track record of instructing and mentoring team members through a new process.
- Highly skilled at setting up and running fill lines within an isolator environment.
- Proficient working in a digital environment (MES, Tulip, etc.).
Nice To Haves
- Bachelor's Degree in science, manufacturing or engineering.
- Proven background working within an MES environment.
Responsibilities
- Support the process design, qualification, startup and registration of high volume filling lines.
- Provide hands-on technical input for the new large volume manufacturing facility.
- Partner and collaborate with 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.
- 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 factory and site acceptance testing to ensure that equipment is suitable for end-user execution.
- Support equipment qualification (e.g. smoke studies) and process validation activities.
- Support the creation of the site’s media fill program.
- Provide end user feedback for the creation of the MES program.
- Serve as an SME for regulatory inspections.
- Transition into a routine position in the site and extend into daily operation responsibilities following go-live.
- Be responsible for filling operations following cGMP, PQS and Safety standards while maintaining a teamwork attitude to effectively manage production needs and meet the production schedule.
- Independently perform aseptic set up of the high speed fill lines within an isolator environment.
- Identify and resolve discrepancies, contribute to investigations, troubleshoot technical issues, and address system gaps.
- Execute filling tasks such as line set up, environmental monitoring, interventions, and system breakdown, all 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.
- Demonstrate and train team members on good aseptic techniques within a clean room and isolator environment according to cGMP practices.
- Direct, coordinate, and prioritize daily activities for the team in order to ensure objectives and performance indicators are met.
Benefits
- Relocation benefits are available for this job posting.
- 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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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
