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Validation Engineer

3 months ago

Summit, United States Cynet Systems Full time
Job Description:

Pay Range $74hr - $77hr

Responsibilities:
  • Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures.
  • Develops protocols, and associated reports while adhering to a change management process.
  • Supports the execution of equipment qualifications and validation protocols.
  • Supervises vendors for qualification functions.
  • Supports calibration, equipment qualification and validation activities.
  • Configures and documents the configuration of computerized systems.
  • Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, and Change Controls.
  • Manages projects of varying scope and complexity.
  • Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
  • Independent ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems.
  • Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.
  • Completes all qualification and validation documentation with accuracy, completeness, and compliance to Company standards.
  • Provides excellent customer service and support.
  • Regularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests.
  • Provides technical support and guidance on calibration and equipment qualification issues. Interfaces with customers to ensure all expectations are being met.
  • Maintains a positive relationship with all team members and site customers while promoting a positive team environment.
Knowledge Skills and Abilities:
  • Strong working knowledge of MS Windows client and server technologies.
  • Working knowledge of standard networking principles and technologies.
  • Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry.
  • Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance.
  • bility to work with the end user to identify and document User and Functional Requirements.
  • Knowledge of pharmaceutical laboratory and manufacturing systems.
  • Experience executing equipment qualification documents.
  • bility 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. Ability to effectively manage multiple tasks and activities simultaneously.
  • Strong written and verbal communication skills along solid presentation skills.
  • Proficient at writing well-formulated emails and reports.
  • bility to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task.
  • bility 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.
  • ction Oriented.
  • ttention to Detail.
  • Multi-tasking.
  • Building Relationships.
Education and Experience:
  • Required BS degree in Engineering / Computer Science.
  • 5 years of experience in FDA-regulated industry, with min 3 years' experience in CSV.
Requirements:
  • Lab w/o blood & animal.
  • Position Handles Hazardous Materials.
Working Condition:
  • Environmental Conditions:
  • Environment may include working in office or in a laboratory / manufacturing area.
  • bility to work safely in an environment with hazardous, radioactive, and infectious materials and waste.
  • bility to work safely when working alone or working with others.
  • This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.
  • The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
  • This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.
  • There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job.
  • Employees holding this position will be required to perform any other job-related duties as requested by management.