Validation Engineer
AstraZeneca

Job Info

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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 outstanding 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 ambitious but highly rewarding work, involves more than 675 hardworking 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.

As a Validation Associate Scientist I/Engineer, you are expected to provide technical solutions to a wide range of critical issues in compliance with organizational objectives. As such you should have a complete understanding and be responsible for a wide application of technical principles, theories, and concepts in the field of Validation. Represent the organization by providing solutions to difficult technical issues associated with specific projects. You are a member within a highly motivated team responsible for ensuring maintenance of compliance and supporting commercial biologics manufacturing under current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) environment.

What you'll do:

• Write, approve and execute validation protocols, generate reports, regulatory submissions, and audit responses
• Lead and 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
• Interact with cross-functional stakeholders to facilitate project/protocol execution as necessary. Provides technical solutions to a wide range of difficult problems.
• Write validation master plans related to specific projects and coordinate project meetings related to execution of the validation master plan
• Write validation site specific and multi-site procedures, guidelines and gap assessments and governance documents
• Support implementation of change requests and resolution of process deviations through technical knowledge, execution of supporting validation studies, and manufacturing documentation review and approval
• Implement standard work and lean processes within area of responsibility
• Able to read P&ID, Isometric and "As Built" drawings

Minimum Qualifications:

• Bachelor's Degree in Engineering or Technical field
• 5-7 years' experience in any area of Validation
• Experience in any of the following; cleaning validation, shipping validation, computer systems validation, Facility, equipment, and/or utility validation

Preferred Qualifications:

• Experience performing, commissioning verification, IQ/OQ/PQ studies on large facility equipment and automated systems
• Autoclave and/or vessel SIP validation
• FAT and SAT experience with large equipment/automated systems
• Project management experience associated with facilities upgrades and major construction projects
• A questioning attitude and drive to develop solutions to complex problems requiring ingenuity and creativity/innovation is key.

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 ambitious - 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!

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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