Engineering_Computer System Validation Engineer III/IV
Novartis - Broomfield, CO

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The Engineer - Computer Systems Validation will perform all or some of the following Job description:
  • Provide oversight to all aspects of validation, principally computer systems validation, equipment, and facility validations
  • Assure that documented evidence exists to provide a high degree of assurance that the operation and maintenance of all systems are consistently reproducible, meet the required standards and specifications, and all computerized systems comply with laid down requirements
  • Review and approve validation protocols, validation reports and assure appropriate support documentation is included
  • Author computer system validation documents
  • Respond promptly to customer needs, resolve technical and tactical operational problems within the scope of the position and draft and/or review documentation such as plans, scripts, and qualification protocols
  • Serve as a member of project teams for new equipment, facility upgrades and validations
  • Lead and / or participate in local and regional teams in CSV project initiatives and be the CSV Subject Matter Expert for all FDA, Corporate or other regulatory inspections
  • Lead and / or participate in investigations to ensure thorough root cause analysis is conducted and CAPA implementation is effective and sustained
  • Monitor validation systems and implement corrective actions as necessary. Minimum requirements • Bachelor’s Degree in Engineering or a Scientific discipline and 4 years of experience in pharmaceutical computer system validation.
  • Demonstrated knowledge and technical understanding of pharmaceutical unit operations
  • Demonstrated knowledge in two or more of the following: pharmaceutical computer systems, equipment, facilities, utilities and/or automation
  • Demonstrated knowledge of cGMPs and Good Document Practices (GDPs)
  • Detail orientated, organizational, technical writing and presentation skills
  • Must be a team player prepared to lead, work in and embrace a team-based culture
  • Ability to communicate and collaborate with technical and management staff within Manufacturing, Engineering, Technical Services and Quality
  • Project management skills, including creating / managing project budgets, resources (internal and external) and schedules
  • Ability to lead and direct complex assignments with little or guidance
  • Ability to provide solutions to a variety Validation issues
  • Ability to manage multiple projects at one time
  • Ability to deal successfully with difficult personalities
  • Execute small capital projects and preventative action plans.

Novartis - 2 years ago - save job - block
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About this company
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Novartis AG, incorporated on February 29, 1996, is a Switzerland-based holding that, through its subsidiaries, is engaged in the research,...