Validation Supervisor

Overview FUJIFILM Irvine Scientific, Inc. is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific, Inc. adheres to ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company's consultative philosophy and expertise in cell culture and compliance provide customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific, Inc. has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services.  FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation, reporting to FUJIFILM Holdings Corporation. We are hiring a Validation Supervisor. The Validation Supervisor will oversee and coordinate all of the validation activities for the site, including supplier/vendor validation activities. External US Responsibilities Responsible for maintaining and updating the Routine Validation Schedule, Project Validation Schedule, and Master Validation Plan. Responsible for internal audit findings, customer responses, and other validation-related support. Lead and support the execution of qualification/validation protocols (IQ/OQ/PQ/PV/CV/CSV), including the collection of samples, data, and test results. Compile and analyze validation data, prepare reports, and make recommendations and/or improvements. Ensure that management is notified of major deviations from protocol criteria as well as lead/support the identification of root causes and resolutions. Coordinates the scheduling of protocol execution and testing with affected departments and personnel. This includes, but is not limited to: Manufacturing, Quality Assurance/Control, R&D and Facilities. Create, revise, assess, and review documents such as protocols, reports, SOPs, batch records, etc. Train operators or other staff on qualification/validation/study protocols and standard operating procedures, as applicable. Support the execution of commissioning protocols such as Factory Acceptance Testing (FAT) / Site Acceptance Testing (SAT), as applicable. Lead and support the development of project plans and timelines. Lead and support the tracking of project goals and collaborating with cross-functional teams. Supervise and guide Validation Specialists and Validation Engineers as well as oversee their activities. Other duties as assigned. Required Skills/Education BS in Bioengineering, Chemical Engineering, or equivalent STEM degree. A minimum of 6+ years performing qualifications/validations in a medical device, pharmaceutical, or food manufacturing industry. 4+ years in a relevant validation role. 2+ years leading and/or managing teams. Knowledge of study design (e.g., DOE). Advanced knowledge of process validation, cleaning validation, and computerized system validation. Advanced knowledge of equipment/system/facility qualifications. Knowledge of FDA/cGMP/QSR and associated guidelines relevant to validation. Knowledge of microbiological and biochemical comprehension; technical proficiency. Ability to speak, read, and write English proficiently. Proficient oral and written communication skills. Proficient presentation skills. Salary and Benefits: For California, the base salary range for this position is $99,400 to $129,000 annually. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.). Medical, Dental, Vision Life Insurance 401k Paid Time Off EEO/AGENCY NOTES Fujifilm is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation, and any other status protected by federal, state, or local law. To all agencies: Please, no phone calls or emails to any employee of Fujifilm about this requisition. All resumes submitted by search firms/employment agencies to any employee at Fujifilm via-email, the internet or in any form and/or method will be deemed the sole property of Fujifilm, unless such search firms/employment agencies were engaged by Fujifilm for this requisition and a valid agreement with Fujifilm is in place. In the event a candidate who was submitted outside of the Fujifilm agency engagement process is hired, no fee or payment of any kind will be paid. *#LI-onsite

Created: 2024-11-05