Qualification Engineer

Teva Pharmaceuticals • Edison, NJ

379d

About The Position

The Qualification Engineer II at Teva Pharmaceuticals is responsible for leading equipment and utilities qualification, commissioning, and improvement activities primarily at the Edison site in New Jersey. This role involves acting as a subject matter expert for all qualifications, overseeing qualification activities, and providing technical expertise for engineering process improvement projects. The engineer will also manage smaller equipment and process change projects, ensuring compliance with regulatory standards and facilitating efficient product launches.

Requirements

• Bachelor's degree in engineering or equivalent on-the-job experience/training.
• 7+ years of Qualification or Engineering experience in the 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.
• 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.

Responsibilities

• 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 stakeholders 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 are required along with managing small projects.

Benefits

• Medical, Dental, Vision, and Prescription coverage starting on the first day.
• Disability and Life Insurance.
• Paid Time Off.
• 13 paid Holidays.
• 6% match on the 401(k).
• Employee Stock Purchase Plan.
• Tuition Assistance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree