Computer Software Validation - Equipment (CSV-E) Engineer Job

Job description

Computer Software Validation
- Equipment (CSV-E) Engineer-8589150925DescriptionDePuy Synthes Companies of Johnson & Johnson is seeking a Computer Software Validation
- Equipment (CSV-E) Engineer in Elmira, NY.DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
DePuy Synthes Joint Reconstruction is the Joint Reconstruction business offering orthopaedic devices, solutions and supplies for hip, knee and extremity reconstruction, in addition to cement and operating room products.
The Computer Software Validation
- Equipment (CSV-E) Engineer will have the following responsibilities:Support Computer Systems Compliance activities applicable to country specific regulations (e.g. FDA, Health Canada), international standards (e.g. MDD, ISO) and as appropriate best business practices (e.g. GAMP 5). This includes the creation, execution and coordination of GxP computer system validation activities. Assist in the establishment and maintenance of procedures, tools and methodologies to cover all equipment computer systems lifecycle phases. Follow policies and procedures for computer system validation efforts in production and processing environments. Advise and consult within DePuy Synthes and with suppliers to facilitate timely and complete resolution to computer system validation issues within the production and processing environments. Partner on departmental or company-wide projects for computer software system
- Equipment validations, including, but not limited to machine controllers, PLCs, DNC interfaces, e-records/e-signature compliance, Human Machine Interface, etc. Partner with IT, Business CSV, System Owner and Process Owner to ensure compliance of GxP computer systems lifecycle procedures, tools and methodologies. Assist with audits of current and prospective suppliers of software applications and services. Maintain a working knowledge of applicable FDA regulations and ISO standards associated with computer system validation
- equipment, in order to maintain a state of compliance while providing innovative solutions to meet changing business needs. Assist in 3rd party assessments of the company’s computer system validation – equipment program. Prioritize and manage multiple projects consisting of varying degrees of complexity. Analyze complex problems and apply practical solutions.
QualificationsA minimum of a Bachelors Degree is required. A Bachelors Degree in Computer Science or related technical field is preferred. A minimum of 4 years Computer Software Validation or CSV-E experience in a GMP and/or ISO regulated environment is required. Knowledge of software development and testing methodologies (S/W life cycle) is required. Direct experience supervising computer systems compliance activities in a GMP and/or ISO regulated environment is preferred. Medical device experience is preferred. Experience in managing and/or in performing audits in a GMP and/or ISO regulated environment is preferred. Excellent Organizational and Communication Skills (written and verbal) is required. The ability to create plans and reports as it relates to deliverables and validations is preferred. ASQ Certification as a Software Quality Engineer is preferred. Six-Sigma/Lean Certification a preferred.
This position will be based in Elmira, NY and will require up to 25% domestic travel.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NAPrimary Location:North America-United States-New York-HorseheadsOrganization: Depuy Orthopaedics. Inc. (6029)Travel:Yes, 25 % of the TimeJob Function: Compliance SecurityCertain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. EEO is the Law EEO is the Law GINA Supplement