"Lighting a Path to the Future"

Lead Validation Engineer-Computer Systems

Location: Cincinnati, OH
Job Type: Direct Hire
Salary: $90,000.00 - $110,000.00
Degree: Bachelor;
Date: 12/7/2017
Job ID: 02509772
Job Description

This position provides technical leadership and accountability for computer system validation and ensures compliance with internal and external computerized system policies and regulations.  As the Subject Matter Expert, this individual will ensure sites are fundamentally aware of and proactively implement current computerized system validation practices with particular focus on impact to patient safety, product quality and record integrity.  Position scope includes local and global site systems as well as SaaS (Software as a Service) solutions.

ESSENTIAL AREAS OF RESPONSIBILITY: 

Computer System Validation 

  • Lead computer system validation for local and global sites including automated lab equipment software, data tracking and trending software, quality systems software and associated business system interfaces.
  • Determine computer system validation strategy for system qualification in alignment with company systems and collaborate/lead in decision-making and make recommendations regarding best options.
  • Communicate proactively with stakeholders and management regarding progress, issues and plans for resolution and to ensure the project team and/or network is fully informed of updates and improvements.
  • Develop computer system validation related content; controlled documents to support the start-up, validation, operation and maintenance of site GMP computerized systems, for project qualification plans and protocols.
  • Monitor/support on-going computer compliance and perform periodic system reviews ensuring that the systems maintain their validated status.

Policy Writing and Revision

  • Ensure the site(s) are compliant with current corporate global computerized validation policies and legislative requirements by setting and maintaining computerized system validation standards via computerized system validation SOPs.
  • Author, review or approve the Validation Plans, Computer Validation Protocols and Reports and associated Validation Reports.
  • Ensure all centrally produced tools, templates and materials are available and relevant to site.

Internal, Partner, and Regulatory Audit Support

  • Support Regulatory inspections and internal and partner audits, and implement corrective actions as needed.  Provide Computer System Validation related responses to inspectors/auditors.

 

Project and Budget Management

  • Ensure resources including key personnel, training and experience is in place before beginning computerized system validation activities.
  • Measure and report project execution progress.

Risk Assessment Activities 

  • Ensure that the computer system validation efforts are directed at the systems that have the potential to impact product quality, efficacy and data integrity using a variety of tools including GAMP 5.

 

QUALIFICATIONS:

Minimum Education & Experience Requirements:

BS degree in a technical or scientific discipline including Engineering or Computer Science.  Minimum of five (5) years in the pharmaceutical industry with GMP experience and expertise as a practicing professional in the area of computer system validation. Ten (10) years preferable.

Technical Knowledge/Skills Needed:

  • Areas of expertise include validation of cGMP computerized systems within an FDA regulated environment.
  • Comprehensive knowledge of Validation lifecycles for site and global systems (i.e., IT, Analytical Equipment, Spreadsheets, SaaS (Software as a Service), Oracle, Trackwise, Maximo)
  • Practical experience with quality risk management and risk based validation approaches.
  • Thorough understanding of industry standards and best practices computer system validation such as GAMP 5 and ASTM E2500.
  • Knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9 and Q10.
  • Demonstrated Project Management abilities to lead and manage a high volume of simultaneous projects.
  • Excellent written and verbal communications, including technical writing. Microsoft Office Software, with MS Project.




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