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Manufacturing Systems & Technology Specialist I

Date: Jan 8, 2019

Location: Salt Lake City, Utah, US, 84116

Company: Teva Pharmaceuticals

Company Info

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!

 

This position is located at our facility in Research Park, near the University of Utah (575 Wakara Way, 84108).

 

Job Description

Under general supervision, this individual will determine the critical aspects of manufacturing equipment with regard to product and process, and writes protocols and other records related test results.  Prepares final reports that identify the results of protocol testing and the conditions of release.  Assists in conducting efficiency studies and in the identification of process improvement opportunities.  Participates in project coordination activities.

 

Essential Job Functions 
• Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
• Provides assistance in troubleshooting to manufacturing and packaging areas.
• Interfaces with Quality Assurance and Research & Development (R&D) on process requirements for new and current products.
• Assists with on-site transfer projects and product scale-up activities.
• Recommends improvements in manufacturing and control systems.
• Assures that protocols are approved through proper channels; writes and revises validation protocols.
• Executes validation protocols per related SOPs and assures that acceptance criteria related to validation protocols are met.
• Assures that all test data is gathered and recorded in accordance with cGMP requirements.
• Analyzes data to ascertain if it meets related protocol acceptance criteria; writes deviation reports as required upon failures to meet protocol acceptance criteria.
• Writes reports and assures that they are approved through proper channels.
• Provides support in investigations and other troubleshooting activities.
• Prepares batch record documentation.
• Develops and communicates project timelines and status.
• Complies with all GMP and safety requirements, SOP’s and Company policies and procedures.
• Performs related duties as assigned.

Qualifications

Minimum Qualifications 

 

Education
Bachelor’s degree in Science or related field from an accredited college or university and one (1) to two (2) years experience; or an equivalent combination of education and experience.  Graduate degree preferred

 

Experience/Skills
• One (1) to two (2) years process technician or laboratory experience in a manufacturing environment.
• Knowledge of or ability to learn pharmaceutical manufacturing principles, practices and applications
• Ability to work and contribute in a positive, collaborative and dedicated team environment
• Knowledge of or ability to learn pharmaceutical product equipment qualification/calibration concepts.
• Knowledge of or ability to learn pharmaceutical raw material and finished product tests, results and interpretation
• Experience in writing clear and concise technical documents (Batch Record, Change Control, Protocols, Summary and Evaluation reports)
• Project management experience; ability to simultaneously manage multiple projects, duties, and assignments.
• Ability to read, write and speak English in order to complete and generate training, reports and or revise or update documentation files, databases, and logs accordingly.
• Ability to lift up to 25 lbs, climb stairs & ladders, work in moderate to loud noise environment and wear GMP appropriate attire as required.
• Intermediate skills in Microsoft Office Suites (Word, Excel, Access, PowerPoint, MS Project)
• Intermediate statistical analysis, computations, and test methodology experience; Knowledge of JUMP or MINI TAB helpful.
• Knowledge of or ability to learn current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), OSHA, FDA, EPA, AQMD and other applicable regulatory and safety compliance guidelines.
 

Function

Manufacturing

Sub Function

Technical Transfer

Reports To

MS&T Principle

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, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.


Nearest Major Market: Salt Lake City