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Qualification Engineer I - SLC East (Monday - Friday, Day Shift)

Date: Jun 13, 2024

Location:

Salt Lake City, United States, Utah, 84108

Company: Teva Pharmaceuticals

Job Id: 56425

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

This Systems Qualification Engineer will support the equipment engineering team with Commissioning Documents, Qualification Documents and Project Management in a demanding environment that requires dynamic problem-solving to meet tight deadlines.

How you’ll spend your day

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

• Assists in developing recommendations for enhancing the GMP production process.

• Tracks project deliverables on directly assigned projects.

• Develops Requests for Proposals (RFP), User Requirements (URS), Functional Specifications (FS) and Design Specification (DS) documents.

• Develops and Executes control system qualification documents including Installation Qualifications (IQ), Operational Qualifications (OQ) and Performance Qualifications (PQ)

• Manages and develops cross-functional Computer Systems Validation (CSV) deliverables for senior technical managers with guidance from team leads, skilled engineers, and RA/QA leads, including:

• preparing CSV documentation (IQ, OQ, PQ) including validation plans, test plans, execution results, deviations, corrective actions, summary reports, and other items as directed.

• Interfaces with vendors during the design and implementation of control systems.

• Supporting team efforts for test executions, deviation resolution, and process improvement Initiatives.

• Driving proactively documents submitted into formal workflows.

• Being available as needed, on-site, with scheduling flexibility and determined commitment to meeting set deadlines.

Your experience and qualifications

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

Education/Certification/Experience:

• A bachelor’s degree in an engineering or technical discipline and two-years related experience:

• Or a non-technical degree plus 4 years of experience in systems validation/qualification.

Skills/Knowledge/Abilities:

• Automation, validation, and GMP experience in the pharmaceutical/medical devices industry.

• A detailed knowledge of Good Manufacturing Practices (GMP), GAMP, Good Documentation Practices (GDP), Gap Analysis, and Formal Systems Audits.

• Computer proficiency with comprehensive working knowledge of MS Office products and systems such as HP GALM, HP QC, Trackwise and other computer relational databases.

• Detail oriented with ability analyze information, create metrics and articulate the link to business needs/objectives.

• Interact positively and collaborate with co-workers, management and external partners.

• Knowledge and experience with change control and applicable qualification and validation processes.

• Ability to work in a team environment through conflict resolution and negotiations, influence and lead others with and/or without direct supervisory authority.

• Self-directed with ability to organize and prioritize work.

• Communicate effectively with strong written and oral communication and technical writing skills.

Problem Solving:

• Works on problems of moderate scope where evaluation of contributing factors requires analysis of situation or data.

• Exercises judgment within broadly defined practices and policies and selects methods and techniques for obtaining solutions.

• Selects methods, techniques, and evaluation criteria for obtaining results.

• Acts independently and proactively to recommend methods and procedures for problem resolution.

Enjoy a more rewarding choice

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, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance.

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 (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte_company=1080030P)

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. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

Important notice to Employment Agencies - Please Read Carefully

Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

EOE including disability/veteran