1+ months

Qualification Engineer

Davie, FL 33314

Company Info

If youre like people at Teva, you dare to be different. Were making well-being a way of life for our customers and our colleagues. Join us in helping to make healthcare more accessible to more patients, while supporting one of the most innovative teams in the industry.

Tevas Davie and Sunrise (Florida) production sites are two of our largest launch facilities.   We are strengthening and adding to our critical teams with great talent and capabilities. Teva, a global organization, with a brand of evolving success.  Be part of it!

 

Teva is a global pharmaceutical leader and the worlds largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the worlds largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we have built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description

As a Qualification Engineer, well count on you to:

Provides engineering technical support, as Equipment Qualification SME for manufacturing and packaging processes. Establishes and implements procedures and guidelines that ensure consistent and compliant operation of equipment with repeatable and reproducible results.

 

ESSENTIAL AREAS OF RESPONSIBILITY

  • Preparation and execution of commissioning, installation and operational qualification, and validation protocols for equipment, mechanical, computer control, and utility systems.
  • Develop Qualification master plans, process flow diagrams, test cases, and standard operating procedures. 
  • Develop qualification documents, Functional and Design Specifications, Test Protocols for IQ/OQ/PQ and Summary Reports, supplementing documentation provided by Suppliers/Contractors/OEMs.
  • Execution of Test Protocols, including identification and resolution of non-conformances/deviations.
  • Performs periodic reviews of equipment and system qualifications, prepares summary report, and assigns CAPAs to address deficiencies.  Includes reviews of change controls, deviations, work orders, IQ/OQ, URS, drawings, and FS/DS as applicable.
  • Reviewing Qualification or Test Plans issued by the Suppliers/Contractors for completeness and correctness.
  • Preparing specific User Requirements Specifications (URS).
  • Provide active inputs/participation in FATs, SATs.

 

Qualifications

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

 

Education/Certification/Experience:

  • Bachelors in Engineering required (Chemical or Mechanical preferred)
  • 5+ Years experience - at least 3 years working experience in commissioning, qualification and/or validation activities in Pharmaceutical or related manufacturing environment. Experience in Oral Solid Dosage is preferred. 

 

Skills/Knowledge/Abilities:

  • Ability to read and understand P&IDs, PFDs

Function

Manufacturing

Sub Function

Technical Transfer

Reports To

Site Qualification Lead

Tevas Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.

Categories

Posted: 2019-06-28 Expires: 2019-11-09

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Qualification Engineer

Teva Pharmaceuticals
Davie, FL 33314

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