Position Description

We are hiring a Production Support Tech. The Production Support Tech will support new product introduction transfer process, ensure new products are properly established in business ERP system, evaluate and assign appropriate manufacturing materials associated with the product type being manufactured, and review production batch records for completeness, making necessary corrections to ensure error free documentation is provided to downstream activities. They will also be responsible for ensuring compliance with cGMP and GDP guidelines and company policies, monitor and correct inventory transactions that enable the business to maintain accurate inventory, and participate in cross functional meetings related to manufacturing status and customer order fulfillment.

At FUJIFILM Biosciences, we turn curiosity into breakthroughs that advance the field of life sciences. By offering a comprehensive portfolio of products and services in cell culture media, discovery research reagents, recombinant growth factors and proteins, fine chemicals, and critical assay materials, we partner with the brightest minds in biotech and pharma to tackle the world’s biggest health challenges.

Imagine being part of a team that enables life-changing discoveries like new vaccines, therapies, and advancements in regenerative medicine. Our culture fosters curiosity, collaboration, and innovation, and we pride ourselves on delivering unparalleled quality and service to our partners. If you’re ready to make an impact, your future belongs with us at FUJIFILM Biosciences.

Our headquarters in Santa Ana, California, is surrounded by world-class schools, lush parks, and scenic beaches like Laguna and Huntington, making it an ideal place to live, work, and explore. With additional campuses across the US, Europe, China, and Japan, we offer opportunities to make a difference worldwide.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Responsibilities:

• Review technical transfer documents to ensure the process aligns with GMP capabilities. Review electronic batch records for completeness and accuracy. Observe initial manufacturing runs to document concerns / deviations or process challenges.  Escalate concerns to leadership.
• Work with the Manufacturing Sciences and Engineering team and Manufacturing Support Services team to explore process optimization for NPI considerations.
• Reviews and compiles batch record documentation and materials issuances, in order to assess completeness, accuracy, and conformance to cGMP and GDP standards and company policies. Partner with manufacturing personnel to make corrections to documentation. Provide feedback to operators and department managers related to documentation errors and trends.
• Track errors by type, technician, and process activity. Work closely with production management and technicians to reduce error rate.
• Update various manufacturing and business reports related to performance tracking and work completeness.
• Work cross functionally with other departments, including Quality to resolve issues and/ or questions related to batch record documentation.
• Run inventory reports associated with manufacturing activities. Perform investigations related to inventory discrepancies.  Correct inventory transaction errors.  Work cross functionally with other department leaders.  Participate in meetings related to manufacturing order status and customer order fulfillment. Follow up on action items assigned and escalate concerns or issues to leadership.
• Navigate proficiently in ERP system to complete electronic folder reviews and confirm inventory adjustments are transacted appropriately. Maintains and records production data in the Daily Production Record (DPR) file including units produced, in-process rejects, QC samples, etc.
• Update material issuances in the ERP system for the raw materials/components used during production.
• Other duties, as assigned.

Required Skills/Education:

• B.S. in Biology, Engineering, Chemistry or the equivalent in experience, knowledge and expertise
• 3-5 Years Previous Manufacturing / Quality experience in bioscience, pharmaceutical or medical devices industry.
• Strong working knowledge of GMP, GDP, ISO, FDA and OSHA regulatory requirements. Working experience with ERP system.
• Strong working knowledge of batch records including GMP and GDP rules governing their accuracy and completeness.
• Knowledge of using computers and proficiency in MS Office Suite.
• Knowledge of Metric System.
• Knowledge of weighing of materials and measuring volume in a manufacturing environment.
• Ability to learn processing methods that comply with current Good Manufacturing Practices (GMPs).
• Ability to speak and read English.
• Good oral and written communication skills.

Salary and Benefits:

• For California, the base salary range for this position is $23.46 - $30.50 per hour. 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

*#LI-onsite

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (flbi@fujifilm.com).