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 Philadelphia, PA site manufactures a life-saving influenza vaccine. Our product is aseptically filled into sprayers for nasal administration. The site consists of two geographic locations - a facility at Red Lion Road in NE Philadelphia has about 140 full-time employees and the Bensalem storage and distribution facility has about 5 employees. The facilities are about 8 miles apart and both are situated close to I-95, the city of Philadelphia, and Philadelphia International Airport. Our product is sold in the US, UK and other countries. Operations continue year round, with the production season being in the summer (typically May – August). Our site is highly collaborative where we show our Philly pride in all we do. We work closely together, always striving to be better every day. We have a network of employee teams who deliver many kinds of employee engagement activities, from our famous Wingbowl, to inclusion events, a site picnic, community outreach, health and wellness activities, and a green team.

The Senior Validation Engineer in Philadelphia, PA leads installation, operational, and performance qualification (IQ/OQ/PQ) activities for critical manufacturing equipment, facilities, and utility systems for the site. Acts as validation lead on cross-functional projects and project lead on validation improvement projects.   Provides technical support for formulation, filling and packaging activities including investigations and deviations from the validated state. 

What you’ll do:

• Lead validation activities independently described in validation protocols including thermal studies, cleaning, shipping, computer systems, equipment and utilities qualification and/or validation.
• Maintains an up-to-date knowledge of validation requirements, practices, and procedures.
• Frequent use and application of technical standards, principles, theories, concepts, and techniques.
• Provides solutions to a variety of technical problems of moderate scope and complexity.  Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Provides mentorship to lower-level validation engineers.

Essential for the role:

• BS, MS, PhD or equivalent in a technical or engineering specialty
• BS: 8 years of related experience in biopharmaceutical or pharmaceutical industry OR
• MS: 6 years of related experience in biopharmaceutical or pharmaceutical industry OR
• PhD: 4 years of related experience in biopharmaceutical or pharmaceutical industry
• cGMP operations experience
• Proficiency in the use of the Kaye Validator or equivalent

Desirable for the role:

• Experience with cleaning and sterilization validation
• Project management skills
• Operational Excellence / Lean Manufacturing knowledge

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, pioneering cutting edge methods and bringing unexpected teams together. 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.

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.