DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today’s evolving health care environment. Our broad array of inspired, innovative and high-quality offerings help advance the health and wellbeing of people around the world.
In this key role, you will be responsible for supporting 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).
• Assist in the establishment and maintenance of procedures, tools and methodologies to cover all computer systems lifecycle phases
• Follow policies and procedures for computer systems validation – Equipment
• Advise and consult within DePuy Synthes and with suppliers to facilitate timely and complete resolution to computer systems validation - Equipment issues
• Partner on departmental or company-wide projects for computer systems validation - Equipment including, but not limited to e-records / e- signature compliance
• Partner with IT and System Owner to ensure compliance of GxP computer systems lifecycle procedures, tools and methodology
• Manage or assist with audits of current and prospective suppliers of software applications and services. Maintain a working knowledge of applicable regulations and standards associated with computer systems validation 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 systems validation - Equipment programQualifications
• A minimum of a Bachelor’s degree is required.
• An academic major in Computer Science, Information Technology, or other technical field is highly preferred.
• A minimum of 5 years of Computer System Validation experience in a GMP and/or ISO regulated environment is required.
• Knowledge of software development and testing methodologies (S/W life cycle) is preferred.
• Direct experience supervising computer systems compliance activities in a GMP and/or ISO regulated environment is preferred.
• Medical device and/or pharmaceutical experience are 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.
• Other than English, the ability to communicate in German and other languages 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 requires up to 10% travel, with a potential for international travel.
United States-New York-HorseheadsOrganization
Depuy Orthopaedics. Inc. (6029)Job Function