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MS&T Specialist II - 7416

Date: Nov 25, 2022

Location: Fairfield, US, 00000

Company: Teva Pharmaceuticals

Who are we?

Teva is a global pharmaceutical leader and the world's 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 world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've 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

The MS&T Specialist is responsible for supporting validation activities as it pertains to manufacturing, packaging and cleaning processes at the Teva Fairfield, NJ facility.  The position also requires executing projects on equipment qualifications, equipment installations, process/formulation troubleshooting, process optimization and writing process related investigations. Has understanding of pharmacological, compliance and industry factors.

Essential Duties / Functions

  • Complete assignments pertaining to qualification/validation of equipment, processes and cleaning in support of manufacturing of new and existing equipment/products. Typical assignments at this level would advance to include (but not limited to) development of protocol associated for equipment, process and cleaning validation projects and process evaluation studies.
  • Perform execution of validation and evaluation/engineering study protocols.
  • Prepare final report packages by analyzing results and preparing summaries of the data to support test and protocol requirements.
  • Complete assigned investigations and CAPA actions within scheduled timelines. 
  • Maintain a positive working relationship with peers and plant personnel to facilitate the completion of assignments.
  • Communicate the status of project activities and possible issues that may impact the progress of projects to supervisor, project teams and other management, as needed.
  • Prepare technical documentation to support regulatory filings such as batch records, process descriptions, etc., as needed. 
  • Prepare and update Standard Operating Procedures (SOPs) as needed.
  • Other duties as assigned by the Associate Director MS&T.

Qualifications

Master Degree in Engineering (Preferably Chemical Engineering) or Pharmaceutical Sciences   OR  B.S. Degree in Engineering (Preferably Chemical Engineering) or Pharmaceutical Sciences

  • 2 plus years of related experience
  • Prior experience in pharmaceutical manufacturing, validation, quality assurance, or process control / practices is desirable.
  • Proficiency in at least one functional area i.e. process validation or cleaning validation or process development scale-up & optimization is desirable
  • Able to independently execute assigned responsibility with minimum supervision
  • Knowledge of current Good Manufacturing Practices (cGMPs) and applicable government regulations is required.
  • Good written and oral communication skills is required. Knowledge of Good Documentation Practices is required.
  • Experienced in the use of statistical analysis software such as JMP or Stat Graphics is preferred.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Function

Manufacturing

Sub Function

Technical Transfer

Reports To

Associate Director MS&T

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s 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.