8 days old

Process Engineer (Pharma Manufacturing)

Irvine, CA 92606
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 Irvine, CA production site is one of our complex manufacturing and supply chain operations.
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!

We offer a competitive benefits package including Medical, Dental, Vision and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee Stock Purchase Plan and Tuition Assistance

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

Teva is searching for a Process Engineer to join our MS&T team in Irvine, CA!

The Process Engineer is a specialized position, considered a Subject Matter Expert in planning, documentation, and execution of equipment, process, and cleaning validation activities. This role will be working in a cross-functional matrix organization to support tech transfer activities of the new products.

You will:

  • Write technical validation protocols/reports, for Regulatory or Compliance requirements. Write, review, or revise SOPs as related to validation policies or revalidation activities.
  • Use quality management system to write validation deviations investigations, product impact assessments and ensure corrective and preventative actions in place.
  • Validate and revalidate new or modified products, equipment or systems. Establish validation standards.
  • Perform extensive technical reviews of validation protocols and interpret data for accuracy of equipment/process performance for completed validations/revalidations.
  • Provide technical support and guidance to other validation personnel and/or project team in protocol/report preparation, execution, and data interpretation.
  • Provide technical assistance and expertise for answering questions or concerns from customers or regulatory agencies in reference to validation activities/principles.
  • Independently author protocols and final report packages by analyzing results and preparing summaries of the data to support test and protocol requirements. Develop and maintain validation related documentation, which may include specifications, SOPs, work instructions or batch or testing records.
  • Independently perform execution of validation protocols and use data analysis skills in assuring accurate interpretation of data.
  • Work with cGMP requirements for commercial manufacturing. Assist in the generation of relevant regulatory sections of filings, data capture and management, process monitoring and trending, including control charting and statistical process control, and support regulatory and site inspections.
  • Ensure processes, products, equipment or systems comply with all applicable external regulations or standards.
  • Work under direct supervision and from detailed verbal and/or written instructions. Use established procedures to accomplish assigned task.
  • Follow Teva Safety, Health, and Environmental policies and procedures.
Qualifications
  • Bachelors degree in Biological/Life Sciences or Engineering required.
  • 2-4 years of experience in pharmaceutical manufacturing or related field preferred.
  • Minimum of 2 years of experience in validation activities in a parenteral manufacturing facility or related field preferred.
  • Minimum of 3 years of experience in writing and executing equipment and process validations required.
  • In-depth knowledge of equipment, process, and cleaning validation to support manufacturing, cGMPs, CFRs, pharmaceutical equipment and processes required.
  • History of and current participation in related professional organizations preferred.
Function
Manufacturing
Sub Function
Technical Transfer
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.

Categories

Posted: 2020-10-12 Expires: 2020-11-15

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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Process Engineer (Pharma Manufacturing)

Teva Pharmaceuticals
Irvine, CA 92606

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