Validation and Qualification Expert

7 days ago

Summit, New Jersey, United States LanceSoft Full time
Job Summary

We are seeking a highly skilled Validation and Qualification Expert to join our team at LanceSoft. As a key member of our Lifecycle Management team, you will be responsible for ensuring the validation and qualification of equipment and systems in compliance with policies, guidelines, and procedures.

Key Responsibilities
  • Maintain all qualified and validated equipment and systems in compliance with policies, guidelines, and procedures.
  • Support the development and execution of equipment qualifications and validation protocols.
  • Develop and maintain written procedures for calibration and preventive maintenance of equipment.
  • Configure and document the configuration of computerized systems.
  • Develop validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, and Change Controls.
  • Manage projects of varying scope and complexity.
  • Support laboratory and manufacturing equipment implementation projects, including scheduling, procurement, site preparation, installation, qualification, and turnover to business areas.
  • Own all lifecycle deliverables in the qualification of equipment and full CSV for single and multi-user Computerized Systems.
  • Support internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.
  • Complete all calibration, qualification, and validation documentation with accuracy, completeness, and compliance to Client standards.
  • Provide excellent customer service and support.
  • Regularly review, prioritize, and respond to customer equipment qualification and support requests.
  • Provide technical support and guidance on calibration and equipment qualification issues.
Requirements
  • Strong critical thinking skills.
  • Ability to learn and function in a fast-paced environment.
  • Experience executing qualification documents.
  • Ability to interact effectively with laboratory, QA, and Facilities groups.
  • Strong ability to organize assigned tasks in a high-paced environment and concurrently monitor tasks/assignments with others that may impact timely completion.
  • Strong written and verbal communication skills, along with solid presentation skills.
  • Proficient at writing well-formulated emails and reports.
  • Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task.
  • Ability to effectively communicate with employees, contractors, and vendors.
  • Experience with technical writing and document development/generation.
  • Strong computer skills in Microsoft Office Suite - Word, Excel, Visio, and Outlook, and the ability to learn new software as required for equipment qualification.
Competencies
  • Technical/Professional Knowledge.
  • Problem Solving/Troubleshooting.
  • Action Oriented.
  • Attention to Detail.
  • Multi-tasking.
  • Building Relationships.
Education and Experience
  • BS degree in Engineering/Computer Science or equivalent.
Working Conditions
  • Environment may include working in an office or in a laboratory/manufacturing area.
  • Ability to work safely in an environment with hazardous, radioactive, and infectious materials and waste.
  • Ability to work safely when working alone or with others.

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