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Validation Engineer II
$101k-117k (estimate)
Full Time | Pharmaceutical 2 Weeks Ago
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Amneal Pharmaceuticals is Hiring a Validation Engineer II Near Branchburg, NJ

Job DescriptionJob SummaryThe Validation Engineer II is responsible for performing validation and Engineering activities, conducting development studies, analyzation and assist in improving pharmaceutical systems and processes.
Essential Functions
  • Design, review and execute validation document activities such as Factory acceptance test (FAT), Installation qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for equipment /utilities/facilities and generate reports which summarize results, specification and its acceptance criteria
  • Performs re-qualification of equipment, facility and utilities as required
  • Responsible for creating validation project and validation progress reports - weekly and monthly
  • Participate in evaluation of failures and out of specification results impacting compliance with quality, safety and other design requirements
  • Provide Technical Inputs and develop strategy for various domestic and international Site Transfer projects. Provide regular status updates to the department and program management.
  • Closely works with the maintenance & facility teams to complete new equipment installation, commission and validation as per project requirement.
  • Performs engineering assessment and writes investigation reports for non-conformance
  • Additional Responsibilities
  • Assists with engineering projects and performs other duties as assigned.
QualificationsEducation
  • Bachelors Degree (BA/BS) in Pharmaceutical manufacturing, Engineering, Science or relevant field - Required
Work Experience
  • 2-5 years experience in engineering, pharmaceutical industry, cGMP environment - Required
Skills And Abilities
  • Proficient in MS Office. - Advanced
  • Excellent technical writing skills - Intermediate
  • Excellent oral and written communication skills. - Advanced
  • Must be able for follow direction and execute assigned work independently, after initial training is completed - Advanced
  • Ability to work both independently and in conjunction with a team - Advanced
Specialized Knowledge
  • Read, understand and verify piping & instrument diagram, engineering layout, drawing and documents
About UsAmneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.

Job Summary

JOB TYPE

Full Time

INDUSTRY

Pharmaceutical

SALARY

$101k-117k (estimate)

POST DATE

06/02/2024

EXPIRATION DATE

07/03/2024

WEBSITE

amneal.com

HEADQUARTERS

GLASGOW, KY

SIZE

3,000 - 7,500

FOUNDED

2002

TYPE

Public

CEO

DARREN SHIRLEY

REVENUE

$1B - $3B

INDUSTRY

Pharmaceutical

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About Amneal Pharmaceuticals

Amneal is a pharmaceutical company that develops and commercializes generic and specialty drugs.

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