Amneal Pharmaceuticals

Associate Validation Engineer

Amneal Pharmaceuticals  •  Brookhaven, GA (Onsite)  •  3 hours ago
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Job 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.

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
Amneal Pharmaceuticals

About Amneal Pharmaceuticals

Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.

Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions.

Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam.

Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or drugsafety@amneal.com. If you are currently experiencing a life-threatening event, please immediately contact 911.

Industry
Chemicals & Materials
Company Size
5,001-10,000 employees
Headquarters
Bridgewater, New Jersey
Year Founded
2002
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