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Senior Qualification Engineer

Date: Jun 19, 2019

Location: Davie, Florida, US, 33314

Company: Teva Pharmaceuticals

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 Davie and Sunrise (Florida) production sites are two of our largest launch facilities.   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!

 

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 have 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

As a Senior Qualification Engineer, we’ll count on you to:

To be responsible for assisting/leading the qualification and requalification activities of equipment, facilities, utilities and computerized systems, which includes but not limited to:

  • Development, implementation and execution of the Site Qualification Plan, qualification/commissioning documentations from project conception to delivery of the qualified system.
  • Design and define specification documents, qualification strategies and deliverables such as URS, FS, DS, TM, FAT/SAT, IQ, OQ, PQ, periodic qualification assessments.
  • Provides technical input and assist in the interpretation of regulations (FDA, MHRA, Canada Health, Anvisa, WHO, etc) and policies.
  • Provide resolutions to issues by analyzing root causes and discerning the most appropriate corrective actions for problems or deviations during the project lifecycle.
  • Provides project leadership and guidance on qualification initiatives to internal project teams and external validation firms and ensure project timelines and deliverables are met.
  • SME in Qualification during any regulatory and third party audits.

Essential Job Functions:

  • Develop and executes qualification project plans, DQ, IQ, OQ, PQ, final reports, specification documents (URS/DS/FS/FAT/SAT), periodic assessments, risk assessments, site qualification master plans and standard operating procedures.
  • Actively participate in executing policies and any regulatory commitments to ensure processes and equipment/systems are maintained in a qualified state and meets sustainable cGMP compliance.
  • Perform effective root cause analysis, problem solving, resolution, and provide leadership to team members and cross-functional groups for the implementation qualification projects.
  • Resolve testing problems by modifying testing methods or revising test objectives and standards. 
  • Participate in the Implementation of Risk Management and criticality assessment techniques to highlight critical equipment, identify failure modes (FMEA) and implement strong controls for risk mitigation.

Qualifications

  • Education: BS degree in Engineering (Mechanical, Electrical or Chemical preferred)
  • Experience: 8+ Years’ experience - at least 5 years working experience in commissioning, qualification and/or validation activities within Pharmaceutical environment (Oral Solid Dosage experience preferred).
  • Experience in the following areas is a plus: Facilities (cGMP rooms, HVAC, Water Systems, Compressed Air, and Process Equipment.

Skills:

  • Ability to read and understand P&ID’s, PFD’s
  • FDA/Regulatory standards, ASTM E2500, ISPE guidelines for Equipment qualification and validation.
  • Thorough understanding of Validation life cycle approach.
  • Concise and organized writing of technical data.
  • Works with multiple departments to gather and summarize findings
  • Understands manufacturing equipment functional parts including control systems, mechanical components, and electrical power. 
  • Related experience from other industries considered

Strong Problem Solving and RCA Skills

Function

Manufacturing

Sub Function

Technical Transfer

Reports To

Site Qualification Lead

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.


Nearest Major Market: Fort Lauderdale
Nearest Secondary Market: Miami