Teva Qualification Engineer II 

United States, North Carolina 

324484432

Under general supervision, the

• Carries out responsibilities in accordance with the organization’s policies, procedures, and state, Federal and local laws.
• Reviews electrical, mechanical, and software/computer specifications in manufacturer and blue print form, and identifies critical parameters.
• Writes protocols (IQ/OQ/PQ) that challenge the critical parameters related to installation, operation, and performance of the related facility, utilities, computer systems, or equipment.
• Assures that protocols are approved through proper channels; writes and revises validation protocols.
• Executes validation and qualification protocols per related SOPs and assures that acceptance criterion related to validation and qualification protocols are met.
• Assures that all test data is gathered and recorded in accordance with cGMP requirements.
• Writes final reports and assures that they are approved through proper channels.ps and communicates
• Develops and communicate project timelines and status.
• Complies with all GMP and safety requirements, SOP’s and Company policies and procedures.
• Performs related duties as assigned.
• Performs periodic reviews of equipment and system qualifications, prepares summary report, and assigns CAPAs to address deficiencies. Includes reviews of change controls, deviations, work orders, IQ/OQ, URS, drawings, and FS/DS as applicable.
• Receives instruction, guidance and direction from others.

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

• Bachelor’s in Engineering required (Chemical or Mechanical preferred)
• at least 2 years of experience within pharmaceutical or related manufacturing facility
• Prefer previous experience in a manufacturing environment within pharmaceutical, nutraceutical or food processing industries.
• Experience in development and execution of qualification protocol/reports as related to automated equipment/systems preferred.

• 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
• Responding to common inquiries or complaints from internal customers, regulatory agencies and management.
• Interpreting software changes, diagrams and flowcharts, design drawings (blue prints) and/or construction drawings and specifications including but not limited to HVAC, CA, Water Systems.
• Communicating clearly and concisely, both orally and in writing.
• Strong technical writing skills.
• Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and related federal, state and local laws codes, regulations and regulatory requirements.
• Pharmaceutical principles, practices and applications.
• Principles and practices of qualification and validation.
• Techniques and principles of sampling, testing and measuring of mathematical calculations.
• Mechanical and electrical concepts.
• English usage, spelling, grammar and punctuation
• Personal computer operations and Microsoft applications (Word, Access, excel, Powerpoint, Projects and Visio).
• Ensuring compliance with all company policies and procedures, including safety rules and regulations.

We offer a competitive benefits package, including:

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.

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