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Genentech

Biotech firm creating medicines via R&D

Senior Master Manufacturing Technician - Filling Operations

Machine & Process OperationConfirmed live in the last 24 hours
Full-timeHolly Springs, NC, USA

About the Job

Requirements

  • A minimum of a high school education and 9 or more years of related production experience, or an associate degree and 7 or more years of technical related experience in the pharmaceutical industry, supply chain management, or manufacturing.
  • Recognized subject matter expertise in filling operations.
  • Strong understanding of aseptic principles.
  • Proficient knowledge and experience with SAP or ERP systems.
  • A proven track record of instructing and mentoring team members through a new process.
  • High skill in setting up and running fill lines within an isolator environment.
  • Proficiency working in a digital environment, such as MES or Tulip.
  • Ability to work in controlled environments as required.
  • Flexibility to work overtime and adjust the schedule beyond a normal work week, with the schedule subject to change based on the project phase or commercial demand.

Responsibilities

  • Support process design, qualification, startup, and registration of high-volume filling lines at the new facility.
  • Provide hands-on technical input as an end user for design and startup activities, partnering with Engineering, MSAT, Quality, Supply Chain, Technical Development, Regulatory, CMO, and Strategy organizations.
  • Provide knowledge and training on complex process and equipment technologies to required partners.
  • Develop training materials and train people joining the organization; coach colleagues with less experience and help them develop skills and expertise.
  • Support authoring standard operating procedures for new equipment.
  • Support factory and site acceptance testing to ensure equipment is suitable for end-user execution.
  • Support equipment qualification, including smoke studies, and process validation activities.
  • Support creation of the site's media fill program.
  • Provide end-user feedback for creation of the MES program.
  • Serve as a subject matter expert for regulatory inspections.
  • After facility go-live, perform routine filling operations in accordance with cGMP, PQS, and safety standards while managing production needs and meeting the production schedule.
  • Independently perform aseptic setup of 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, including line setup, environmental monitoring, interventions, and system breakdown, while focusing on quality and efficiency.
  • Complete and review process-related documentation, communicate with teams, support training activities, and report departmental metrics.
  • 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 in a clean room and isolator environment according to cGMP practices.
  • Direct, coordinate, and prioritize daily team activities to ensure objectives and performance indicators are met.

Desired Qualifications

  • A bachelor's degree in science, manufacturing, or engineering.
  • A proven background working within an MES environment.

About the Company

Genentech

Biotech firm creating medicines via R&D

Genentech develops medicines and therapies to address unmet medical needs through extensive biotechnology research and development. Its products include biologic and small-molecule treatments prescribed by healthcare providers and sold through partnerships with suppliers and health systems. It differentiates itself with a large R&D footprint, a vast patent portfolio, and FDA Breakthrough Therapy Designations that accelerate promising therapies. Its goal is to advance medical science and deliver high-quality, effective therapies that improve patient health while supporting the broader medical community.

Company size
10,001+
Company stage
IPO
Headquarters
San Francisco, CA
Founded
1976

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