Teva Qualification Engineer 

United States, New Jersey 

259332448

The Qualification Engineer II has responsibilities for equipment and utilities qualification, commissioning, and improvement activities at the Teva Edison Site in NJ primarily and occasional projects at Teva Fairfield site in NJ. In addition to leading equipment qualification projects, the Qualification Engineer II acts as a subject matter expert (SME) for all qualifications at the Edison Site. This individual is responsible for performing and overseeing equipment, utility, and facility qualification activities, while providing technical expertise for complex engineering process improvement projects. Moreover the individual will be expected to act as a project manager for smaller equipment as well as process change projects.

Essential Duties / Functions

• Lead Site Expansion and Renovation activities, including Commissioning and Qualification for Facility, Utility, and Equipment systems, with minimal supervision.
• Develop and review Validation / Qualification protocols and reports that challenge the critical parameters related to installation, operation, and performance of related facility, utilities, computer systems, or equipment.
• Analyze complex datasets to ensure adherence to protocol acceptance criteria; author deviation reports and provide root cause analyses and corrective/preventative actions
• Act as a primary technical writer and reviewer for engineering turnover packages and design documentation to support qualification.
• Oversee and participate in factory acceptance testing and commissioning support, ensuring compliance with company and regulatory standards.
• Collaborate with Engineering, Operations, Supply Chain and other stake holders to facilitate efficient launch requirements needed for new products packaging, ensuring alignment with qualification and validation requirements.
• Lead the development of User Requirement Specifications (URS) and Functional Requirement Specifications (FRS) for validation-related projects.
• Execute and provide technical leadership for Engineering Studies to establish robust equipment operating parameters.
• Ensure compliance with the Site Validation Master Plan and Validation Project Plans, proactively addressing risks and gaps in qualification processes.
• Develop and manage project timelines, resource allocation, and status communication for qualification initiatives.
• Mentor and train junior team members, fostering skill development and knowledge transfer within the engineering team.
• Support regulatory inspections and audits, serving as an SME for qualification activities including the ones done in the past.
• Work in a self-directed manner and must be able to work on problems of a complex scope where in-depth evaluations of various factors is required along with managing small projects.
• Perform other duties as assigned by the Engineering management.
  

Education:

• Bachelor’s degree in engineering or equivalent on-the-job experience/training

Experience:

• 7+ years, Qualification or Engineering experience in a pharmaceutical industry, preferably in a production/packaging setting.
• In depth knowledge of qualification requirements for pharmaceutical operations including packaging, utilities, CSV, automated control systems, HVAC and equipment engineering.
• Specialized Skills / Technical Knowledge, Licenses, Certifications:
• Knowledge of Current Good Manufacturing Practices ( cGMP), Food and Drug Administration (FDA), OSHA and related federal, state and local laws, codes, regulations and regulatory requirements
• Knowledge of pharmaceutical manufacturing operations to support the approval of protocols, reports, procedures and specifications.
• Strong Understanding of Process Controls and Systems Integration preferably associated with solid oral dose / packaging equipment
• Independent, motivated individual with ability to deliver on and manage multiple projects
• Advanced troubleshooting & problem-solving skills.
• Understanding of safety and equipment procedures.
• Ability to work with heavy equipment, climb steps, lift and push objects.
• Proficient in English usage, spelling, grammar and punctuation
• Proficient at communicating clearly and concisely, both orally and in writing.

Physical Demand Requirement
Incumbents in this class are subject to extended periods of sitting, standing, walking, pushing and pulling, stooping and crouching climbing and walking, vision to monitor, occasional lifting of equipment or materials weighing up to 25 pounds. Incumbents may be exposed to toxic materials, toxic gases, electrical hazards, and dangerous tools and equipment. Work is performed in a manufacturing environment.

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