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 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, powders and liquids to 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.

We are a team of results-oriented people, who want to go far, and we’re all here to achieve. It’s what drives us to be proactive and solutions-focused. At every stage of production, we step up and take accountability to deliver, each of us feeling responsible for the outcomes. What we do is important and valued – we make a real-life difference to patients.

The Senior 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.

What you’ll do:

• 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 and solves qualification and cleaning validation execution issues using critical analysis skills and develops sound, reasoned solutions and recommendations.
• Leads all aspects of 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.
• Participates in the validation activities associated with all Quality Investigations, internal and external audits and 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.

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 and 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.

Preferred:

• 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.

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. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, groundbreaking cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!

Next Steps – Apply today!

To be considered for this great 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 an excellent fit, please share this posting with them.

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Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.