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Sr. Validation Engineer / Validation Engineer - Mt. Vernon - Global Operations

Location Mount Vernon, Indiana, United States Job ID R-075282 Date posted 02/24/2020

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Sr. Validation Engineer / Validation Engineer in Mt. Vernon, IN, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

Global Operations is fundamental to our purpose of delivering life-changing medicines to patients, touching every aspect of our business and providing a platform for everything that we do. We harness the specialist talents of 13,000 people around the world – 20% of our global workforce. With 30 production facilities in 18 countries we’re focused on supplying our medicines with care, quality and efficiency, reducing the time from lab to patient. Keen to bridge the gap between science and patients? Turn research into reality? And forge a global career that’s full of possibilities, as part of a world-class team? Come and thrive in our vibrant, energizing, connected and supportive culture and make a real difference to patients.

This position could be filled as a Sr. Validation Engineer or Validation Engineer depending on experience.

The Sr Validation Engineer / Validation Engineer performs installation and operational and performance qualification (IQ/OQ/PQ) of critical manufacturing equipment, facilities, and utility systems for the site. Performs cleaning validation activities for new products and maintains existing products. The Validation Engineer provides technical support for process manufacturing and packaging including investigations and correction of cleaning process-related problems and deviations from standards.

Responsibilities:

  • Performs installation and operational and performance qualification (IQ/OQ/PQ) of critical manufacturing equipment, facilities, and utility systems. Responsibilities include newly installed equipment and systems as well as previously qualified equipment and systems, which are modified through Change Control and periodic assessments of equipment, facilities, and utility systems.
  • Develops and reviews qualification protocols and reports, coordinates system and equipment documentation collection, and executes protocols.
  • Develops and reviews cleaning validation protocols and reports, coordinates room and equipment documentation collection, and executes protocols.
  • Solves qualification and cleaning validation execution issues using critical analysis skills and develops sound, reasoned solutions and recommendations.
  • Works with Operating Technicians and Maintenance during fieldwork and execution of protocols.
  • Oversees capital qualification services related to Formulation and/or Packaging and performs peer review of contract/consulting documentation.
  • Performs fieldwork such as checking systems and equipment that are located in manufacturing areas, on mezzanines and rooftops, and in mechanical spaces or penthouses.
  • Represents the Validation group in Change Control meetings and in Departmental qualifications and cleaning validation discussions.
  • Verifies red-line drawings to “as-built” status.
  • Performs assessments to determine if re-qualification and/or re-validation is needed in accordance with local procedures.
  • Maintains and enhances reliable and responsive working relationships with internal and external customers and suppliers.
  • Participates in the validation activities associated with all Quality Investigations.
  • Participates in the internal and external audits; able to defend own and others protocols and reports.
  • Supports the Validation Manager in managing the Site Validation Master Plan and Master Schedule including all aspects of design qualification, verification, installation qualification, operational qualification, performance qualification, process and cleaning validations for formulation, packaging, equipment, computer systems, critical utilities, and equipment cleaning.

Qualifications:

Sr. Validation Engineer

Required:

  • Bachelor’s degree required, preferably in Engineering, Chemistry, Biology, or Pharmaceutical Sciences.
  • At least 5 years of relevant validation experience in the pharmaceutical industry. A combination of education and relevant experience will be considered.
  • Experience in conceptual development, project management (planning and scheduling projects), design, and implementation of major capital projects.
  • Experience in the pharmaceutical industry and related regulatory, engineering, and construction techniques is highly desirable.
  • Knowledge and understanding of validation and qualification principles, project management, and change control principles.
  • A solid base and application experience in pharmaceutical manufacturing plants and/or research facilities, and/or related environmental projects, material handling, containment, and utility/infrastructure support facilities.
  • Demonstrated ability to effectively communicate and collaborate across all levels of the organization including with customers, vendors, equipment suppliers, and Operations staff.
  • General knowledge of basic electrical codes, safety guarding, and labeling.

Desirable:

  • Six Sigma green belt or equivalent experience is preferred.

  • Experience with IQ/OQ/PQ, Cleaning Validation, and Lean Manufacturing is highly desirable.

  • Experience in the pharmaceutical industry and related regulatory, engineering, and construction techniques is highly desirable.

Validation Engineer

Required:

  • Bachelor’s degree required, preferably in Engineering, Chemistry, Biology, or Pharmaceutical Sciences.
  • 0-3 years of relevant validation experience in the pharmaceutical industry. A combination of education and relevant experience will be considered.
  • Experience in conceptual development, project management (planning and scheduling projects), design, and implementation of major capital projects.
  • Knowledge and understanding of validation and qualification principles, project management, and change control principles.
  • Demonstrated ability to effectively communicate and collaborate across all levels of the organization including with customers, vendors, equipment suppliers, and Operations staff.

Desirable:

  • Six Sigma green belt or equivalent experience is preferred.
  • Experience with IQ/OQ/PQ, Cleaning Validation, and Lean Manufacturing is highly desirable.
  • Experience in the pharmaceutical industry and related regulatory, engineering, and construction techniques is highly desirable.

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 embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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