We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.
The Validation Engineer II is an entry-level position within the engineering department of FDBU. The primary purpose of this position is to develop and execute validation protocols for automated equipment/systems in compliance with IQ/OQ/PQ requirements and applicable regulatory and cGMP guidelines.
Under close to moderate supervision, the Validation Engineer II is expected to perform the daily validation functions in support of automated equipment/systems in accordance with FDBU standards and regulatory requirements.
This position requires basic knowledge of equipment process automation and FDA regulation 21 CFR 11.
This position will report directly to the Associate Director of Engineering but may also have a functional reporting relationship to a senior colleague on a project-to-project basis.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Develop and execute validation protocols in compliance with IQ/OQ/PQ requirements and the Site Master Validation Plan strategy
- Review and approve equipment/system specifications such as User Requirement, Functional, and Design
- Works with operations, automation, and facilities during protocol execution
- Develop, revise and abide by standard operating procedures and engineering documents.
- Solves protocol execution issues using critical analysis and develops sound, reasonable solutions
- Performs validation activities associated with Quality investigations
- Able to interface and build collaborative partnerships with multiple site functions including Manufacturing, Technical Operations, Engineering, and Quality to deliver site goals and objectives
- Other duties as assigned
- Proficient computer skills with experience using MS Office software
- Basic knowledge of IQ/OQ/PQ requirements in a regulated industry
- Basic knowledge of FDA regulation 21 CFR 11
- Basic knowledge of process control and equipment automation in a manufacturing facility
- Excellent organizational, verbal and written communication skills with the ability to effectively communicate within cross-functional teams and to management
- Excellent interpersonal skills and ability to work effectively and efficiently in a team-based environment with employees at all levels
- Self-starter and detail oriented
- Ability to manage commitments while displaying an eagerness to learn and continuously improve
- Excellent presentation skills with the ability to clearly articulate sound reasoning and data when recommending courses of action
- Ability to discuss normally encountered technical issues, both verbally and written, in a manner that is understood by non-automation personnel
- S. Degree in Engineering, Chemistry, Biology or Pharmaceutical Sciences or 5+ years’ equivalent experience in a regulated work environment.
FDBU 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. FDBU 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.
FDBU 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.