Teva Qualification Engineer 

United States, North Carolina 

931618717

This position is responsible for performing activities related to design, installation, qualification and transfer of equipment, facilities, utilities throughout equipment and facilities lifecycle. Executes studies and trials with Research and Development (R & D), MS&T, engineering and vendors as appropriate. Provides documentation, direction and training to other staff, technicians and manufacturing operators.

• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
• Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
• Adapting Operational Excellence (OpEx) initiatives to improve throughput, reduce waste, improve safety of the existing equipment, utilities and facilities. Coordinate activities with various departments and prepare technical reports.
• Performing periodic reviews, statistical assessments, trend analysis and generate leading and lagging KPIs.
• Performing investigations to identify the root causes and actively seek remediation approaches and implement Corrective and Preventive Actions (CAPAs)
• Provide Technical assessments/ product impact assessment summaries on time
• Execute the trials and studies in coordination with planning, manufacturing, quality, MS&T, engineering and PM groups.
• Review and analysis of the process, analytical and statistical data to support the qualification and validation work. Analysis of data to ascertain the data meets protocol and product acceptance criteria: writes deviation reports and technical assessments as required.
• Identify and coordinate the equipment requirements with R & D, Engineering, Employee Health and Safety (EHS), and PM groups in preparation of Capital Expenditure Request (CER) for the commercial scale pre-validation development/ scale up of the ANDA lots.
• Participation in internal (Corporate and QA audits) and external (FDA, MHRA) audits.
• Remediation of the audit related observations (if any) and timely completion of the action items (if any)
• Maintenance of appropriate documentation of protocols, reports and laboratory note books as required by Standard Operating Procedures (SOPs) and internal policies.
• Lead process and equipment automation and modernization projects, creating automated trending and dashboards
• Actively participate in commercial pre-validation and provide technical support to the manufacturing and quality teams as required.
• Leading multiple new technology introduction, upgrades and automation.
• Responsible for performing additional related duties as assigned.

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

Education/Certification/Experience:

• Requires a college fresh Ph.D. or Master’s degree with a minimum of 3 months relevant experience in the field of Pharmaceutical manufacturing and/or pharmaceutical formulation and/or pharmaceutical process development and pre-validation in chemistry or related field.

Skills/Knowledge/Abilities:

• Ability to prepare various types of complex high quality technical documentation (Qualification package) Change Controls (CC), protocols, summary reports, technical assessments and deviation/investigation reports etc.
• Ability to handle multiple projects, duties, and assignments.
• Solving practical problems and considering a variety of concrete variables in situations where only limited standardization exists.
• Leadership skills for providing guidance and training to assigned personnel.
• Ability to contribute in a team environment.
• Communicating clearly and concisely, both orally and in writing; good presentation skills.
• Operating scientific and personal computers.
• Establishing and maintaining cooperative working relationships with others.
• CGMP, FDA, Occupational Safety and Health Administration (OSHA), Environmental Protection Agency (EPA), DEA and other regulatory requirements.
• Pharmaceutical solids manufacturing principles, practices and applications.
• Advanced Opex and statistical computations (Cpp, Cpk, Regression analysis, etc.) and use of statistical software (JMP, Minitab, Statease etc.).
• Process improvement and OPEX.
• Technology transfer and project management principles.
• Ability to use Power BI and other BI tools, develop automation

Problem Solving:

• Proactively works on problems of a complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.
• Seeks out all resources when selecting methods and techniques for obtaining results.
• Acts independently and proactively to direct method and procedure for problem resolution.
  

Senior Director, MS&T

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