Validation Engineer/Senior Validation Engineer
AstraZeneca

Philadelphia, Pennsylvania

This job has expired.


Do you have experience with 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 groundbreaking 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 exciting 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. Our network of employee teams deliver many kinds of employees 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 job responsibilities for both roles are listed below.

This is a multi-career level role. The Job Responsibilities summarized below, represent the full scope of the role. The qualifications at the different career levels are also described.

Validation Engineer:

  • Write validation protocols and reports; Good technical writing skills.
  • Perform validation activities 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.
  • Collaborates with validation and metrology contractors when required.
  • Interacts with Manufacturing Science and Technology and Facilities / Engineering departments to facilitate protocol execution.
  • Communicate optimally with operations and other departments with respect to workload, priorities, and issues to maintain validation schedule.
  • Frequent use and application of technical standards, principles, theories, concepts, and techniques.
  • Provides solutions to a variety of technical and practical problems of moderate scope and complexity with concrete variables in situations where only limited standardization exists.
  • Follows established procedures and standard ways of working to ensure technical soundness, overall adequacy and accuracy.
  • Proficiency in the use of the Kaye Validator or equivalent equipment is desirable.
  • Experience with cleaning and sterilization validation desirable.

Minimum Qualifications:
  • Bachelors: Engineering or Technical Field Preferred.
  • 0-5 years with related experience in biopharmaceutical or pharmaceutical industry.

Senior Validation Engineer:
  • Independently lead validation activities described in validation protocols/projects 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.
  • Write validation protocols and reports.
  • Works with validation and metrology contractors when required.
  • Interacts with Manufacturing Science and Technology and Facilities / Engineering departments to facilitate protocol execution as vital.
  • Communicate optimally with operations and other departments to maintain validation schedule.
  • Frequent use and application of technical standards, principles, theories, concepts, and techniques.
  • Provides solutions to a variety of technical and practical problems of moderate scope and complexity with concrete variables in situations where only limited standardization exists
  • Mentor and collaborate across all validation engineers.
  • Conduct activities and interactions consistent with AZ values & behaviors in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Finish the required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance.

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

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!

Find out 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

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.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.


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