Do you have experience leading installations and performance qualification (IQ/OQ/PQ) activities for critical manufacturing equipment? Would you like to apply your expertise to impact a company that follows science and turns ideas into life-changing medicines? If so, our Validation / Sr. Validation Engineer position in Philadelphia, PA might be the position for you!

AstraZeneca is at an exciting time of new products and launches. We get to work with innovative and scientific products on our leading-edge end-to-end end supply chain, using the latest technologies and modern facilities.

In Operations, we have a big ambition – to deliver more medicines to patients, quicker and more affordably. Backed by the investment, leadership, and a clear plan to get there, we bring personal dedication and out-of-the-box thinking.

Join the team where everyone feels a personal connection to the people that we impact. From our science labs to manufacturing at scale, we are committed to delivering at the highest quality. It’s inspiring and rewarding work, influencing every part of the product lifecycle to deliver life-changing medicines. To ultimately make people’s lives better – from patients and their families to all of us in society.

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.

This position will be filled as either a Validation Engineer or Sr. Validation Engineer based on the successful candidate's capabilities and experiences.

The Validation / Sr. 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:

Validation Engineer

• Perform validation activities described in validation protocols including thermal studies, cleaning, shipping, computer systems, equipment and utilities qualification and/or validation

• Good technical writing skills

• 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.

• Works under general supervision.  Follows established procedures.  Work is reviewed for soundness of technical judgment, overall adequacy and accuracy.

​​Required:

• Bachelors:  Engineering or Technical Field Preferred

• 0-5 years with related experience in biopharmaceutical or pharmaceutical industry

Desired:

• Proficiency in the use of the Kaye Validator or equivalent desirable

• Experience with cleaning and sterilization validation desirable

Sr Validation Engineer

• 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.

Required:

• 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

Desired:

• Experience with cleaning and sterilization validation

• Project management skills

• Operational Excellence / Lean Manufacturing knowledge

Why AstraZeneca?

At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth, and development.

So, what’s next:

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

More on Social Media:

• LinkedIn https://www.linkedin.com/company/1603/

• Facebook https://www.facebook.com/astrazenecacareers/

• Instagram https://www.instagram.com/astrazeneca/?hl=en

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

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.