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Computer System Validation Engineer
Requisition ID: 7906171221
DePuy Synthes Companies of Johnson & Johnson is seeking a Computer System Validation - Equipment Engineer to be located in Monument, CO.
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.
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). This includes the creation, execution and coordination of GxP computer system validation activities
Position duties and responsibilities
- Ensure personal compliance and support departmental compliance to Corporate Compliance, Human Resources and training requirements.
- Perform the following duties as necessary to support company needs:
- 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.
- Advise and consult within DePuy Synthes and with suppliers to facilitate timely and complete resolution to computer systems validation issues.
- Partner on departmental or company-wide projects for computer systems validation 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 creative solutions to meet changing business needs.
- Assist in 3rd party assessments of the company’s computer systems validation program Education
- Bachelor’s degree and greater than 2+ years Computer System Validation experience.
- Knowledge of software development and testing methodologies (S/W life cycle)
- Experience in managing and/or in performing audits in a regulated environment is a huge plus.
- Direct experience working in and/or supervising computer systems compliance activities in a medical device, pharmaceutical or other highly regulated industry.
- Ability to prioritize and handle numerous projects consisting of varying degrees of complexity
- Ability to analyze complex problems and apply practical solutions
- Previous experience working in a manufacturing environment is required
- Excellent Organizational and Communication Skills (written and verbal).
- Six-Sigma/Lean Certification is a plus
- ASQ Certification as a Software Quality Engineer is a plus
- Desired - experience in managing and/or in performing audits in a regulated environment.
- Direct experience working in and/or supervising computer systems compliance activities in a medical device and/or pharmaceutical company.
- The position may travel, up to 10%.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.Johnson &Johnson Family of Companies are equalopportunity employers, and all qualified applicantswill receive consideration for employment withoutregard to race, color, religion, sex,sexual orientation, gender identity, geneticinformation, national origin, protected veteranstatus, disability status, or any othercharacteristic protected by law.
Depuy Orthopaedics. Inc. (6029)