Teva Qualification Engineer - SLC East Monday Friday Day Shift 

United States, Utah, Salt Lake City 

439849933

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.

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.
  

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.

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