Johnson & Johnson Careers
Computer System Validation – Equipment Engineer II
Requisition ID: 9738180423
- 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 preferred in computer science or other technical field or an AS Degree and greater than 5 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%.
Depuy Orthopaedics. Inc. (6029)