Validation Engineer II
The Validation Engineer II, under minimal supervision, will be responsible for drafting and executing utility, process systems and process support systems qualification test work across multiple GMP facilities as well as support cleaning and process validation when necessary. Preparing validation summary reports for the qualification and validation of systems used to manufacture drug or biologics products.
Develop, implement and maintain equipment and systems qualification and validation protocols. Systems include:
Refrigerators, Freezers, and Cold Rooms
Steam and Dry Heat Sterilizers
Clean Gas Utilities
Purified Water and Water For Injection
Process Chromatography Systems
- Execute, track and manage protocols
- Prepare and present report packages for implementation into SOP requirements
- Prepares validation master plans for facilities, equipment, and systems.
- Prepares and executes validation protocols.
- Prepares validation report packages.
- Provides expert opinion in the drafting and implementation of validation studies.
- Coordinates the timely execution of validation activities.
- Performs others duties as may be assigned.
- cGMP experience
- Bachelor of Science preferably in Life Sciences, Chemical or Mechanical Engineering
- 4 years of experience in validation activities in facilities, commissioning, and systems qualification of which at least 1 year must be in a lead role.
- Experience with Thermal Data Loggers as well as pre and post calibration procedures.
- Working knowledge of cGMP compliance.
- Excellent written and oral communication skills.
- Knowledge of utility and process systems associated with the manufacture of a biopharmaceutical product.
- Strong working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, PowerPoint).
- Ability to work with minimal supervision.
- Working knowledge and expertise in clean room qualification.
- Working knowledge and expertise in steam sterilization processes.
- Working knowledge and expertise in computerized systems validation.
The Company requires that the successful candidate hired for this position be fully vaccinated for COVID-19, absent being granted an accommodation due to medical, pregnancy, or sincerely held religious belief or other legally required exemption.
FDBN works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company's ability to secure an export authorization.
FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email firstname.lastname@example.org.
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.