Fate Therapeutics is seeking a talented and highly motivated individual to work with our Facilities, Manufacturing, Process Sciences, and R&D teams to provide hands-on Calibration and Metrology support, equipment management services, and asset management system support. The successful candidate will schedule and assist in the maintenance and calibration of equipment utilized by R&D and GMP end-users, in conjunction with third party resources. The successful candidate will support the Equipment Management team, complying with cGMP, SOPs and applying GDP (Good Documentation Practices). This individual will oversee that contractors are trained on our SOPs and complete the tasks in a compliant manner, ensuring that the necessary documentation is completed accurately. This is a full-time position working the 2nd shift (12pm to 10pm) and is located at our corporate headquarters in San Diego, California.
Responsibilities
- Complete calibrations and maintenance activities with accurate and timely GMP documentation following Company SOPs.
- Assist with equipment onboarding and data entry into the asset management system.
- Read quality control manuals and testing specifications to obtain data to test and / or calibrate specific devices.
- Support the maintenance of all facilities working standards (manufacturing, utilities and labs).
- Use of hand tools and precision measuring and calibrating instruments and equipment.
- Interact with other departments and personnel to resolve any calibration or equipment issues.
- Provide guidance and recommendations on selection of instruments and operational parameters.
- Maintain a safe work environment; work in a safe manner following all safety SOPs and wear Personal Protective Equipment as required.
- Maintain accurate record keeping of equipment and systems while being cGMP compliant.
- Work independently and make sound judgments regarding work methods and tools.
- Work with third party Vendors while performing services on the equipment to ensure that all are following Company and GMP policies.
- Review, investigate, and report on the identification of Out of Tolerance (OOT) conditions. Assist with investigations and corrective actions to preclude the recurrence of similar issues.
- Keep inventory of equipment critical spare parts.
- Support investigations, change controls, RCAs, or new projects.
- Execute and/or ensure that assigned Calibrations and Work Orders (WO) are completed per schedule.
- Maintain equipment lists and enroll new equipment into calibration and maintenance schedules. Generate weekly and monthly system reports.
Qualifications
- Bachelor’s degree preferred.
- 4+ years of equipment maintenance and calibration/metrology related experience in the biotech or pharmaceutical industry.
- Must have an excellent understanding of GMP, lab operations, and asset management.
- Mechanical knowledge of equipment and tools, including their designs, uses, repair, and maintenance such as Biosafety Cabinets, incubators, centrifuges, refrigerators, freezers, and other general laboratory equipment.
- Broad knowledge of GMP principles, concepts, practices and standards in the US and internationally.
- Broad knowledge of 21CFR Part 210 and 211.
- Requires the use of basic math skills and the ability to use technical calibration equipment.
- Ability to troubleshoot basic electrical, programmable logic controllers (PLC), plumbing systems and issues.
- Proficient problem-solving abilities and detail orientation.
- Ability to work and communicate cross-functionally.
- Good written and verbal communication and interpersonal skills.
- Self-motivated, flexible, able to prioritize, multi-task, and work in a fast-paced & dynamic environment.
- Specific calibration and metrology training preferred, or ability to be trained.
- Experience with IBM Maximo or Blue Mountain preferred.
Working Conditions and Physical Requirements
- 100% on-site work at corporate headquarters in San Diego, CA
- Swing shift (12pm – 10pm) will be required
- Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.
$33 - $43 an hourThe preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.
Equal Employment Opportunity
Fate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.
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About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s effector cell pipeline includes multiplexed-engineered, iPSC-derived natural killer (NK) cell and T-cell product candidates, which incorporate novel synthetic controls of cell function, such as chimeric antigen receptors (CARs) to target tumor-associated antigens and are intended to deliver multiple mechanisms of therapeutic importance to patients including in combination with well-established cancer therapies. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.
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