DePuy Synthes, a Johnson & Johnson company is hiring a Computer Systems Validation Engineer that can be located in West Chester, PA or 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 will 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, we are creating one organization that will be agile and better equipped in 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.
In this key role, you will be responsible for 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 life-cycle 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 program.
• Bachelor’s degree is required preferably in computer science or other technical field
• A minimum of 3 years Computer System Validation - Equipment experience is required.
• Knowledge of software development and testing methodologies (S/W life cycle) preferred.
• The ability to create progress and reports as it relates to deliverables and validations is preferred.
• Desired - experience in managing and/or in performing audits in a regulated environment is preferred
• Direct experience working in and/or supervising computer systems - equipment compliance activities in a regulated industry is required.
• Ability to prioritize and manage multiple projects consisting of varying degrees of complexity
• Ability to analyze complex problems and apply practical solutions
• Excellent Organizational and Communication Skills (written and verbal)