Amneal Pharmaceuticals

Associate Validation Engineer

Amneal Pharmaceuticals Brookhaven, NY
Amneal Pharmaceuticals

Associate Validation Engineer

Amneal Pharmaceuticals Brookhaven, NY
2 weeks ago 74 applicants

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Job Description

Description:

The Validation Engineer I provides support in performing equipment, facility and utility qualification activity and re-qualification activity to ensure compliance to cGMP and Amneal's quality requirements.

Essential Functions:


  • Assist in the preparation/ execution of Installation Qualification(IQ)/Operational Qualification(OQ)/ Performance Qualification(PQ) protocols for equipment, facility and utilities as well as related software. Help generate qualification report and help summarize the results which will be reviewed by the supervisor
  • Performs re-qualification of equipment, facility and utilities as required under supervision
  • Identify deviations encountered during IQ/OQ/PQ execution and work with supervisor to implement mitigation solution
  • Draft Standard Operating Procedure(SOP) for new operational equipment
  • Supports process validation and cleaning validation by providing product contact surface area, equipment qualification parameter ranges and challenge tests criteria to technical service
  • Works with equipment vendors to collect equipment manual and other required documents
  • Closely works with the maintenance & facility teams to complete new equipment installation as per project requirement.


Additional Responsibilities:


  • Assist with engineering projects and performs other duties as assigned.


Qualifications

Education:


  • Bachelors Degree (BA/BS) Degree in Pharmaceutical manufacturing, Engineering, Science or relevant field - Required


Experience:


  • less than one year in 0-2 years of experience in Engineering, Pharmaceutical Industry, cGMP environment with Bachelor degree.
  • 1 year or more in Experience in Engineering, Pharmaceutical Industry, cGMP environment with Bachelor degree.


Skills:


  • Proficient in MS Office. - Advanced
  • Excellent technical writing skills. - Intermediate
  • Excellent oral and written communication skills. - Intermediate
  • Must be able for follow direction and execute assigned work independently, after initial training is completed. - Intermediate
  • Ability to work both independently and in conjunction with a team - Advanced

  • Seniority level

    Entry level

  • Employment type

    Full-time

  • Job function

    Quality Assurance

  • Industries

    Pharmaceutical Manufacturing

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