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Sr. Validation Engineer - Pharma
Ref No.: 20-00396
Location: Summit, New Jersey
Job Description:
  • Support Computer System Validation Projects and Equipment Qualifications which support Lab Operations
  • Support the implementation and validation activities of new and upgrades to laboratory software and instrumentation.
  • These activities include technical analysis and design; executing, testing, developing validation deliverables and managing change requests.
  • Address technical and compliance challenges in all phases of the System Validation Lifecycle; research, test, and generate solutions and mitigations.
  • Technical Support: Provide technical input to address validation deviations, provide technical assessments for change requests, identify qualification/validation requirements to ensure GMP compliance, assist in the design, analysis, execution and approval of IQ, OQ, PQ, and UAT protocols and reports, and perform technical reviews of validation deliverables.
  • Develop technical support manuals and provide technical input to address system troubleshooting and administration post system release.
  • Be able to quickly learn and configure new applications, system architecture, and instrumentation with or without vendor assistance and training.
  • Develop, review and approve validation/qualification deliverables such as Validation Plans, Requirements Specifications, Configuration Specifications, Traceability Matrices, Summary Reports, Change Controls.
  • Communication: Effectively communicate the status of all validation/qualification projects to management and to all affected stakeholders.
  • Keeps track of lessons learned and shares those lessons with team members.
  • Work with the Business on gathering analytical requirements.
  • Ensure requirements are feasible and testable.
  • Take on a role of a project manager, coordinate vendors, end users, IT, and other parties as needed to successfully complete projects based on agreed upon timelines.

Qualifications:
  • Must have Pharma
  • Must have equipment qualification
  • Seeking local candidates
  • BA/BS in IT/Engineering discipline or Life Sciences with experience working in IT/technology roles
  • 5+ years experience in FDA-regulated industry
  • 7-10 years experience in equipment qualification
  • Strong instrumentation and computer system validation background and experience in laboratory operations
  • Excellent knowledge of cGMP in the pharmaceutical/biotechnology industry
  • Excellent computer skills
  • Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently.
  • Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required