MS&T Validation Technology Associate

AstraZeneca; Frederick (MD); On-site; USD 69,000 - 104,000; Full time

Benefits offered by this job

Tuition reimbursement

Award-winning employer

Job summary

AstraZeneca's Frederick Manufacturing Center (FMC) is a biologics manufacturing facility that helps deliver life-changing medicines to patients worldwide. The site employs over 675 people across manufacturing and support offices, with ongoing skill-building and tuition reimbursement programs.

We value inclusion, continuous learning and collaboration, supporting career growth through training, cross-functional teamwork and a culture of safety and operational excellence.

Qualifications

• High school diploma or GED with 4 years of experience.
• MS with >0 years relevant experience.
• BS with >2 years relevant experience.
• BS/BA/MS in Science or Engineering, Biological/Physical Sciences, or equivalent focus of study.

Responsibilities

• Expected to work primarily in collaboration with others with some independent work.
• Works under general supervision to meet project goals.
• Projects are assigned by supervisor who is a higher-level scientist or manager.
• Supports scale-up and technology transfer of manufacturing processes to commercial facility, process performance monitoring; implementation of process improvement strategies.
• Makes detailed observations, analyzes data, and interprets results.
• Prepares precise technical reports summaries, protocols, quantitative analyses, and maintains appropriate documentation.
• Present findings at internal meetings and may contribute to the preparation of reports and protocols.
• Provides solutions to a variety of problems of diverse scope involving basic scientific principles.
• Work is reviewed for soundness of technical approach.
• Recommendations consistently result in project advancement.
• Contributes to technology, development or support programs.
• Attention to detail
• Ability to work in a cross-functional team environment
• Focus on operational excellence and lean mindset and behaviors
• Focus on safe behaviors

Skills

Project management

Education

High school diploma or GED

MS with relevant experience

BS with relevant experience

BS/BA/MS in Science or Engineering

Job description

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-winning 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.

Job Responsibilities

• Expected to work primarily in collaboration with others with some independent work.
• Works under general supervision to meet project goals.
• Projects are assigned by supervisor who is a higher-level scientist or manager.
• Supports scale-up and technology transfer of manufacturing processes to commercial facility, process performance monitoring; implementation of process improvement strategies.
• Makes detailed observations, analyzes data, and interprets results.
• Prepares precise technical reports summaries, protocols, quantitative analyses, and maintains appropriate documentation.
• Present findings at internal meetings and may contribute to the preparation of reports and protocols.
• Provides solutions to a variety of problems of diverse scope involving basic scientific principles.
• Work is reviewed for soundness of technical approach.
• Recommendations consistently result in project advancement.
• Contributes to technology, development or support programs.
• Attention to detail
• Ability to work in a cross-functional team environment
• Focus on operational excellence and lean mindset and behaviors
• Focus on safe behaviors

Validation

• Support the execution of validation studies and related activities to ensure compliance with site and regulatory requirements.
• Assist with the preparation of validation protocols and reports in support of validation and qualification activities.
• Compile, organize, and review validation data to support study execution, summary reporting, and documentation completeness.
• Maintain validation documentation and archive protocols, reports, and supporting records as required in accordance with site procedures and document retention requirements.
• Maintain current knowledge of validation requirements, practices, and procedures and apply this understanding to routine validation work.
• Support the development of validation master plans for specific projects.
• Assist in authoring validation procedures, guidelines, work instructions, gap assessments, and governance documents.
• Support the implementation of change controls and the resolution of process deviations through technical input, execution of supporting validation studies, and review of manufacturing documentation.
• Ensure and monitor compliance by team members and third parties by (a) positively reinforcing the Code of Conduct and all relevant AstraZeneca Policies and Standards, (b) ensuring completion of all required training, (c) fostering a culture of openness in which employees are comfortable raising questions or concerns, and (d) immediately addressing and reporting, as appropriate, instances of non-compliance.
• Manager Accountabilities at AstraZeneca include Ethical Conduct and Compliance, Team Management, Performance Management, Individual Development Planning, Talent Management, Recruitment, People information, SHE accountabilities, and Fiscal and Financial awareness.
• Leaders with accountability for GXP areas are expected to understand the legal and regulatory requirements of their roles in providing appropriate resources (which could be human, financial, material, facilities, and equipment) to maintain the Quality system and continually improve its effectiveness.

Education, Qualifications, Skills and Experience

Essential

• High school diploma or equivalent or High school diploma or GED and 4 years of experience
• MS with >0 years relevant experience
• BS with >2 years relevant experience

Desirable

• BS/BA/MS in Science or Engineering, Biological/Physical Sciences, or equivalent focus of study.
• Project Management experience

Compensation & Benefits

• The annual base pay for this position ranges from $69,344- $104,017 (hourly = $33.33 to $50.00).
• Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.
• Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

10-Aug-2026

Closing Date

23-Aug-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.