FUJIFILM Cellular Dynamics is a leading developer and supplier of human cells used in drug discovery, toxicity testing, stem cell banking, and cell therapy development. We partner with innovators from around the world to combine biologically relevant human cells with the newest technologies to drive advancements in medicine and healthier living. Our technology can be used to create induced pluripotent stem cells (iPSCs) from anyone and followed by the powerful capability to develop into virtually any cell type in the human body. Our proprietary manufacturing system result in inventoried iCell® products and donor-specific MyCell® Products in the quantity, quality, purity, and reproducibility required for drug and cell therapy development

We are recruiting for a Validation Engineer to support our investment in  and on-going operation of our cGMP,  research and development, and production facilities in Madison, WI.   You'll be working with our technical operations group along with other highly talented professionals at FUJIFILM Cellular Dynamics, Inc., the leader in induced Pluripotent Stem Cells (iPSC’s) technology.  You will oversee all aspects of validation and qualification of facilities, systems, utilities, and equipment to meet FCDI requirements.  Plan, coordinate, execute and document all aspects related to validation activities, including management of third parties and liaising with Quality and regulatory bodies. This is an excellent opportunity for qualified individuals looking to apply their technical skills and to expand their professional horizons.

Essential Job Functions

1. Perform validation activities for the processes, facilities, utilities, manufacturing, laboratory equipment and software in the pharmaceutical industry in compliance with FDA regulations, Quality Management systems, Good Manufacturing Practices and 21 CFR Part 11 (Electronic Records and Signatures).
2. Develop and execute the validation master plan, validation project plan, risk assessment, user requirements, design qualification and life cycle documents for any improvements in the production methods and ensure compliance with cGMP regulations.
3. Generate the User Requirement Specifications and Impact Assessments to ensure the functioning of the equipment and/or software and determine the impact of the system on the product quality.
4. Perform design review to ensure the equipment and/or software is installed and operates according to the User Requirement Specifications.
5. Perform Commissioning, Qualification and Validation of the equipment, software and systems.
6. Generate and execute validation protocols (IQ, OQ and PQ) for pharmaceutical drug manufacturing and laboratory equipment and/or software, including but not limited to HEPA filters, controlled temperature units, manufacturing equipment and packaging line equipment.
7. Characterize equipment and/or software operation processes and define critical process parameters and critical quality attributes.
8. Write and execute the official test scripts, complete associated documentation for equipment, software and processes to ensure the test results are reported accurately.
9. Author and perform the technical review of deviations and planned deviations, change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), perform activities for lot release (assess deviations and process changes.
10. Participate in client and Regulatory Audits. Work on CAPA and Deviations with minimal but some oversight to achieve quality, timely results
11. Assist with determining impact of change control on qualified process and aseptic operations.
12. Maintain a company-wide equipment database for all facilities, equipment and software under company management.
13. Schedule vendors and contractors for validation activities.
14. Review and approve vendor/contractor issued documentation.
15. Assist with set-up and fit out of lab and supports spaces, as requested.
16. Other job functions as assigned.

• Bachelor’s degree in engineering or Biology related field
• 3 years of related experience with demonstrated achievements and progressive responsibilities
• Familiarity with the FDA Electronic Records and Signatures regulation (21CFR Part 11)
• Familiarity with ISPE GAMP categories and respective CQV practices
• Strong organizational skills
• Proven ability to schedule and coordinate projects or efforts requiring multiple tasks and follow-up
• Demonstrated attention to detail, adherence to procedures and effective communication skills across diverse employee and vendor audiences
• Familiar in use of asset management systems
• Expertise using MS WORD, MS Project, database programs
• Ability to lift 25 pounds repeatedly throughout a normal workday
• Ability to work independently
• Ability to respond to emergency situations after hours, weekends, and holidays as needed

FUJIFILM Cellular Dynamics, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status or status as an individual with a disability. All qualified applicants will not be discriminated against on the basis of a disability.