Validation Engineer Jobs

Validation Engineer

Do you have expertise in, and passion for, manufacturing in a high performing pharmaceutical environment? Would you like to apply your expertise to impact the well-being of patients in a company that follows the science and turns ideas into life changing medicines? We have future Operator opportunities in Formulation and Packaging. See below for specific responsibilities and qualifications for each group.

At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost 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 Mt. Vernon site was established in 1972 and is the flagship site delivering innovative, life changing oral solid medicines. At the site we formulate and pack OSD tablets, capsules for over 60+ markets. The Mt Vernon site is the largest AZ production site in the US and is located in the southwest corner of the state of Indiana, approximately 15 miles from Evansville, Indiana – the third largest city in the state of Indiana. The Mt. Vernon site is dedicated to creating a culture of inclusion and collaboration. We host yearly Inclusion and Diversity conferences and have an employee resource group devoted to promoting diversity and inclusion and enhancing employees' professional development through interactive and engaging events and initiatives.

The Validation Engineer supports the Validation Manager in the execution and management of the Site Validation Master Plan and performs other duties as assigned to support the Validation Department and the site.

What you'll do:

• Works with Operating Technicians and Maintenance during fieldwork and execution of protocols.
• Develops and reviews qualification protocols and reports, coordinates system and equipment documentation collection, and executes protocols.
• 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.
• Performs assessments to determine if re-qualification and/or re-validation is needed in accordance with local procedures.
• Performs fieldwork such as checking systems and equipment that are located in manufacturing areas, on mezzanines and rooftops, and in mechanical spaces or penthouses.
• Oversees capital qualification services related to Formulation and/or Packaging and performs peer review of contract/consulting documentation.
• Solves qualification and cleaning validation execution issues using critical analysis skills and develops sound, reasoned solutions and recommendations.
• Verifies red-line drawings to “as-built” status.
• Represents the Validation group in Change Control meetings and in Departmental qualifications and cleaning validation discussions.
• Performs installation and operational and performance qualification (IQ/OQ/PQ) of critical manufacturing equipment, facilities, and utility systems, and testing instrumentation. 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.

Minimum Qualifications:

• Bachelor’s degree, preferably in Engineering, Chemistry, Biology, or Pharmaceutical Sciences
• Knowledge and understanding of validation and qualification principles, project management, and change control principles
• Excellent verbal, written, and interpersonal communication skills are essential
• Demonstrated ability to prioritize tasks
• 0-3 years of relevant validation experience in the pharmaceutical industry
• Demonstrated ability to effectively communicate and collaborate across all levels of the organization including with customers, vendors, equipment suppliers, and Operations staff

Preferred Qualifications:

• Six Sigma green belt or equivalent experience is preferred
• Experience with IQ/OQ/PQ, Cleaning Validation, and Lean Manufacturing is highly desirable

Why AstraZeneca

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial -finding those moments and recognizing their potential. Interested? Come and join our journey!

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.

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About Operations https://www.youtube.com/watch?v=gak5Ham8oUw