Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Senior Validation Engineer will report directly to the Associate Director, QA Validation at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will be responsible for overseeing the development and implementation of validation strategies. They will perform analysis and compilation of data and resumes into summary and final reports.
The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join our new FDB facility in Thousand Oaks, CA and help manufacture the next cell therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.
The Senior Validation Engineer will serve as the technical subject matter expert for Fujifilm Diosynth Biotechnologies Equipment, Utilities, and Facilities validation program. This individual will work closely with manufacturing, QC, engineering, and facilities to ensure compliance of cGMP systems with all internal Quality requirements.
Reports to: Associate Director, QA Validation
Location: Thousand Oaks, CA
Travel: Up to 10%
- Oversee development and implementation of validation strategies, policies, protocols and other documentation for cGMP systems including: Manufacturing and laboratory equipment, Critical Utilities, and QC equipment.
- Develop, organize, and execute the Validation Maintenance (Requalification) program.
- Develop and execute validation plans and protocols to demonstrate systems are meeting design and functional requirements.
- Perform analysis and compilation of data and results into summary and final reports.
- Supervise contractors in the planning and execution of validation activities.
- Evaluating and performing periodic reviews of validated systems to ensure validated state is maintained. Review/assess proposed validated system changes via CAPA, Change Control and Work Orders to identify requirements necessary to maintain validated status.
- Execute temperature mapping studies for Controlled Temperature Units using Kaye Equipment and software.
- Work with QA to investigate system issues and perform root cause analysis and implement solutions.
- Interface with other departments (e.g., IT, Engineering, Facilities, Manufacturing, Regulatory Affairs, Quality Control and Quality Assurance) to ensure achievement of Fujifilm Diosynth Biotechnologies' objectives relating to validation and associated activities, including compliance, with all applicable standards.
- Bachelor's Degree in an Engineering discipline.
- 5+ years of experience.
- Validation experience in the pharmaceutical industry supporting cGMP systems.
- Experience validating manufacturing equipment, critical utilities, facilities and QC equipment.
- Experience leading full-time and/or contractor personnel in day to day or project related activities preferred.
- Knowledge of relevant regulations and regulatory guidance required to act as a resource for colleagues.
- Independent decision-making capability and ability to think conceptually and understand impact of critical decisions.
- Strong conflict resolution and negotiation skills.
- Excellent verbal and written communication skills; good interpersonal skills.
- Must be able to work in controlled manufacturing environments requiring special gowning.
- Role model for company core values of trust, delighting our customers, Gemba, and Genki.
Join us! FDB is advancing tomorrow's medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.
FDBC 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, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation and any other status protected by state or federal 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.