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Location:
Coppell, Texas, United States
Job reference: R-044507
Posted date: Feb. 07, 2019
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At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.

The Senior Validation Engineer for Computer System Validation will be responsible for assuring the design, installation, implementation, data integrity and validation of computer systems within the PET and Quality Control at the Coppell, Texas site meet all applicable industry standards and regulatory requirements to support the PET goals and targets.

Job Responsibilities

  • Work effectively with others from diverse backgrounds and demonstrate capability to adapt to new, different, or changing requirements.  Display strong moral principles and work ethics while demonstrating initiative.  Maintain a professional presence and display responsible behaviors.
  • Ethical conduct and compliance.
  • Review, prepare and perform qualification and periodic review activities for computer / control systems.  Analyze collected data against pre-determined criteria, and prepare final reports in compliance with relevant regulations, industry practices, and AZ policies and procedures.
  • Coordinate validation and implementation of computerized laboratory instrumentation.
  • Coordinate validation and implementation of manufacturing equipment and systems.
  • May provide supervision and training for less experienced or entry-level validation personnel, including review and enhancement of draft protocols, oversight of data collection, review/approval of raw data and assembled qualification packages.
  • Provide supervision and training for contract validation personnel, including review and enhancement of draft protocols, oversight of data collection, review/approval of raw data and assembled qualification packages.
  • Review the design and implementation of computer/control systems to assure that security and data integrity are maintained.
  • Analyze data and information to determine whether computer / control systems are within an appropriate state of control during qualification and validation as well as in assessing the need for requalification / revalidation on a periodic basis.
  • Prepare, document, and/or evaluate change controls for computer / control systems to ensure that they remain in qualified, validated state.
  • Identify and investigate unusual or unexpected events, data, or sources of variation during the implementation and validation; assess and recommend disposition regarding the impact upon qualification or validation as applicable, and recommend appropriate corrective/preventive actions.
  • Oversight of IT procedures to ensure compliance and consistency within the AZ Pharma GMP environment.
  • Ensure that work is performed in accordance with applicable regulations, industry guidelines and practices, approved procedures and cGMP.
  • Other responsibility as assigned by department management.

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Education, Qualifications, Skills and Experience

  • Bachelor’s degree in a science, technical, or engineering field
  • At least 5 years experience in pharmaceutical or related industry with demonstrated knowledge of computer systems design, qualification, data integrity and validation.
  • Must have attention to detail.  Work requires a high degree of accuracy in complex documentation.
  • Knowledge of computer system and control system design and validation concepts including GAMP.
  • Must understand concepts of qualification and validation as well as sampling, risk evaluation, and detection of variation.
  • Able to work cooperatively with other members of the Validation Team, Quality, Engineering and Manufacturing in the design and performance of qualification and validations.
  • Must effectively evaluate information collected from various sources and determine impact upon controlled state of processes, equipment, facilities, and products.
  • Excellent technical writing and verbal communication skills.
  • Requires the ability to apply scientific and analytical principles for solving problems and proper design of qualifications and validations.
  • Working knowledge of cGMP and other applicable guidelines and regulations.
  • Awareness of qualification of control systems and computer system validation (CSV).
  • Working knowledge of FDA guidance on Process Validation and Computer System validation.
  • Strong background with computer system validation in a FDA regulated environment. Familiarity with 21 CFR Part 11 (Electronic Records/Electronic Signatures), understanding of GAMP 5 validation principles for computer system validation and familiarity with FDA guidance on data integrity.
  • Experience with 1) process control systems,2) manufacturing networks and infrastructure,  3) SCADA based systems and 4) data historians.
  • Preferred experience working with Allen-Bradley Programmable Logic Controllers, WonderWare SCADA applications, Factory Talk SCADA applications, OSI PI data historian.

Key Relationships to reach solutions:

Internal:

  • Operations
  • Facilities
  • IT

External:

  • Equipment vendors
  • Regulatory agencies
  • Contract Validation personnel

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law

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Senior Validation Engineer - Global Operations
Engineering

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