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Validation Engineer

2 months ago

Summit, United States Sunrise Systems Inc Full time

50% onsite required
Work schedule - M- F(Should be flexible on timings based on business needs)

PURPOSE AND SCOPE OF POSITION:

The CSV Engineer supports the successful implementation of manufacturing and laboratory equipment, and computerized systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with equipment qualification and systems validation. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

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.
  • Ability 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.
  • 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. 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. 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:

  • Required BS degree in Engineering / Computer Science
  • Minimum 5 years of experience in FDA-regulated industry, with min 3 years’ experience in CSV

WORKING CONDITIONS (US Only):

Environmental Conditions:

  • Environment may include working in 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 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.

Additional Job Requirements:
Lab w/o blood & animal
Position Handles Hazardous Materials