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 facilitys 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 sites 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. 

Who You Are:

• You possess a 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.

• You are recognized as a Subject Matter Expert (SME) for Filling operations. 

• You possess a strong understanding of aseptic principles. 

• You have proficient knowledge and experience of SAP or ERP systems.

• You have a proven track record of instructing and mentoring team members through a new process.

• You are highly skilled at setting up and running fill lines within an isolator environment.

• You are proficient working in a digital environment (MES, Tulip, etc.)

Preferred qualifications:

• You possess a Bachelors Degree in science, manufacturing or engineering.

• You have a proven background working within an MES environment.

• Work Environment/Physical Demands/Safety Considerations

• This role requires you to be onsite full time, initially at the Genentech project office before transitioning on-site once the site buildings are built and equipment delivered. 

• Travel of up to 30% of the time is expected during the project phase to support facility acceptance testing.

• The environment requires gowning, gloves, steel toe boots and safety glasses (as required).

• Ability to work in controlled environments, as required.

• Candidates must be flexible to work overtime and adjust working schedule beyond normal work week. Work schedule may be subject to change based on the phase of the project and/or commercial demand.

Relocation benefits are available for this job posting.

The expected salary range for this position based in North Carolina is $61,600 - $114,400.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  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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