Irvine Scientific, a member of Fujifilm Holdings Corporation, 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 cell therapy and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large- scale production of biotherapeutics and vaccines. Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 45 years, Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services. Additional information can be found at www.irvinesci.com.
We are hiring for a Worldwide Facilities Director. This Individual will be responsible for developing worldwide facility plans for our growing international organization, including warehousing, manufacturing, security and office space needs. The Worldwide Facilities Director will also coordinate maintenance and upgrade of worldwide facilities and equipment.
- Plan, direct and monitor all facilities activities to maximize the use of the organization’s resources and meet current and long-term business needs
- Supervise and direct contract personnel or outside vendors in the performance of contracted services
- Managing the Facilities department including supervising personnel
- Implementing and documenting preventive maintenance programs on all equipment affecting production of company products
- Compiling and maintaining equipment repair histories
- Coordinating repair and maintenance of equipment with production management
- Installing new equipment and placing it into operation
- Responding to security service alarms to determine and repair source of alarm
- Maintaining reference material (manuals, catalogs, schematics, etc.) to facilitate repairs and PM schedule development
- Developing recommendations for procedure and process improvements
- Proactively supporting the maintenance needs of production departments
- Creating and modifying SOPs as necessary
- Procure contractor services as needed to fulfill capital projects requirements
- Ensures adherence to quality standards and regulations including but not limited to maintaining validated and certified clean rooms, critical utilities systems, and environmental and safety compliance
- Develop request for proposals and make recommendations for working with contractors based on cost, timely completion of projects and quality
- Ensure all facilities comply with OSHA, Air Quality, and local regulations related to building, waste and work environment
- Modify facility and space-related plans to address changes in growth assumptions.
- Communicate facility space status, proposed projects, impact and timing across the organization
- Bachelor’s Degree in Mechanical, Chemical or Electrical Engineering or equivalent experience
- Minimum 10 years’ experience in facility planning or machine maintenance in bio-pharmaceutical/medical device industry
- Experience managing environmental, health and safety programs
- Knowledgeable with WFI systems
- Clean room experience
- 5-10 years of supervisory experience
- Creating and writing SOPs, applications for permits
- Excellent mechanical aptitude
- Filing necessary reports, applications for permits
- Required compliance with local emergency response and environmental regulatory authorities.
- CGMP requirements
- Ability to negotiate vendor contracts
- Excellent organization and interpersonal skills
- Ability to drive continuous improvement
- Ability to quickly establish credibility and earn trust of others at all levels of the organization
- Knowledge of and experience with local, state, federal regulations for office, laboratory and manufacturing facilities
Irvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable 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.
Product Quality Control