CaryRecruiter Since 2001
the smart solution for Cary jobs

Computer System Validation (CSV) Engineer II

Company: FUJIFILM Holdings America Corporation
Location: Morrisville
Posted on: June 25, 2022

Job Description:

Overview Computer System Validation, Engineer II is a mid-level position within the Engineering department of FDBU. - The primary purpose of this position is to develop and execute validation strategies and deliverables for automated equipment/systems and site computerized systems in compliance with IQ/OQ/PQ requirements and applicable regulatory and cGMP guidelines. - This position will also oversee and provide oversight to external contractors and vendors. External US 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.Computer System Validation, Engineer II is a mid-level position within the Engineering department of FDBU. - The primary purpose of this position is to develop and execute validation strategies and deliverables for automated equipment/systems and site computerized systems in compliance with IQ/OQ/PQ requirements and applicable regulatory and cGMP guidelines. - This position will also oversee and provide oversight to external contractors and vendors.Under minimal supervision, this position will provide computerized system validation support for the design, procurement, installation and start-up of the automated and computerized systems in accordance with FDBU standards and regulatory requirements. - - - -This position requires a working knowledge of automated and computerized systems commonly found in pharmaceutical and/or bioprocessing facilities with regulatory requirements to include 21 CFR 11 and with data integrity requirements.This position will report directly to the Sr Engineering Manager, Validation.MAJOR ACTIVITIES AND RESPONSIBILITIES:

  • Develop and execute validation protocols in compliance with local procedures
  • Assess equipment and automation systems to design and implement protocols for validation in compliance with cGMP and regulatory requirements
  • Generate, review, approve computerized system lifecycle documentation including risk assessment, functional specifications, traceability matrices, qualification protocols, validation plans, and summary reports
  • Perform Risk-Based Analysis and define 21 CFR Part 11 compliant approaches to validation
  • Works with operations, users, SMEs, IT, automation, and facilities during protocol execution
  • Develop, revise and abide by standard operating procedures and engineering documents.
  • Able to interface and build collaborative partnerships with multiple site functions including Manufacturing, Technical Operations, IT, and Quality to deliver site goals and objectives
  • Assess the impact to computer system modifications, including upgrades, and maintain change control through closure
  • Other duties as assignedBACKGROUND REQUIREMENTS:Qualifications:
    • Demonstrated knowledge and capabilities authoring validation documents for pharmaceutical manufacturing equipment, control systems, and computerized systems
    • Proficient computer skills with experience using MS Office software
    • 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 personnelEducation/Experience:
      • S. Degree with 3+ years' experience in the pharmaceutical industry or 5+ years' equivalent experience in a regulated work environment. Must include 2+ years' validation experience.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. If an accommodation to the application process is needed, please e-mail .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.

Keywords: FUJIFILM Holdings America Corporation, Cary , Computer System Validation (CSV) Engineer II, IT / Software / Systems , Morrisville, North Carolina

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest North Carolina jobs by following @recnetNC on Twitter!

Cary RSS job feeds