Validation Engineer

Frederick, Maryland

This job has expired.

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.

Our Frederick Manufacturing Center (FMC) is one of 30 production facilities in 18 countries that creates life-changing medicines for people around the world. This biologics manufacturing facility makes a direct contribution to treating people with cancer, respiratory and autoimmune conditions across the globe. It's challenging but highly rewarding work, involves more than 675 talented people throughout the manufacturing lifecycle and supporting office functions. We work hard to deliver life-changing medicines to patients, and we take time to have fun and celebrate our accomplishments. From catered site festivities to competitive events, community outreach activities, environmental and wellness showcases and team-building events, we take time to recognize our achievements.

We are dedicated to creating a culture of inclusion and collaboration. We are committed to continuous learning and offer ongoing skill building and training for our staff and encourage additional secondary schooling with tuition reimbursement of 100% up to $10,000 each year. The FMC is also an award-winning employer and has been recognized as a 'Top 50' Business in Frederick and awarded Frederick County's 'Best Place to Work' distinction in 2015 and 2019. Come join our award-wining team and support the manufacture of life-changing medicines for patients across the world.

Everything we do is to make people's lives better. To us it's personal, as we invent, make, deliver and support. Taking our cutting-edge innovations from our science labs to patients. Fueled by our aspiration to deliver accelerated growth for our company and to make people's lives better, there's never been a more exciting time to shape the next phase of Operations' evolution and growth. We explore, willing to support new ideas, go above and beyond to find better solutions, every day. This is a place for the resilient - hungry for new challenges and diverse opportunities. The driven - willing to learn, take personal accountability and step out of their comfort zone. To build a collective legacy of doing good for people, the environment and society.

Why Join Operations?

Here we turn molecules to medicines, bringing our Research & Development pipeline to life through a rigorous process of development, manufacturing, testing and delivery. In our fast-paced, growing environment, embrace an exciting opportunity to build a long-term, varied career. With a huge variety of global opportunities and learning from other teams this is the place to embrace lifelong learning and build capabilities, setting your own direction and pace.

If you have the passion and the drive to accelerate growth and make people's lives better - then this is the place for you.

As a Validation Scientist in Frederick, MD, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

What you'll do:

  • Write and approve validation IO/OQ/PQ protocols and reports, procedures, guidelines and performs gap assessments
  • Perform/Provide Technical Expertise on validation activities described in validation protocols including thermal studies, cleaning, shipping, computer systems, equipment and utilities qualification and/or validation
  • Responsibilities include scheduling, forecasting project requirements, and preparation of validation master plans.
  • Maintain an up-to-date knowledge of validation requirements, practices, and procedures
  • Work with validation and metrology contractors when required
  • Interact with cross-functional internal stakeholder departments and external vendors to facilitate project execution as necessary
  • Support implementation of change requests and resolution of process deviations through technical knowledge, execution of supporting validation studies, and manufacturing documentation review and approval
  • Defends approach to validation to regulatory agencies. Writes summaries for regulatory submissions and audit responses
  • Present overviews of validation programs to regulatory agencies as necessary
  • Implement standard work and lean processes within area of responsibility
  • Has good technical writing skills. Able to communicate effectively with supervisor, cross functional departments, and senior leadership
  • Able to read P&ID, Isometric and "As Built" drawings
  • Provide technical guidance and coaching for junior team members and facilitate growth and development to build bench strength
  • Bachelor's degree: Life sciences or engineering preferred
  • 5+ years of experience in most of the following areas;
    • Steam-in-Place (SIP) validation of process equipment and Autoclave Load Validation
    • FAT, SAT and commissioning of large automated systems
    • Setting validation specifications for purchasing capital equipment.
    • Project management experience w/ facilities upgrades and major construction projects
    • Cleaning validation
    • Experience in performing IQ/OQ/PQ on large automated systems, facilities/utilities/equipment qualification, and shipping validation
    • Computer systems validation and Environmental monitoring performance Qualification.
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.

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 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 phenomenal fit, please share this posting with them.

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About Operations

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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