MS&T Validation Technology Associate

AstraZeneca•Frederick, MD

About The Position

The MS&T Validation Technology Associate is a key contributor to the MS&T organization. This team enables nimble biopharmaceutical product launches, clinical/commercial drug substance manufacturing, and product lifecycle management. MS&T supports excellence in Upstream and Downstream process optimization and improvement, is an industry leader in process data analytics innovation and application, executes flawless laboratory studies, demonstrates superiority in cleaning, equipment, and EM validation programs.

Requirements

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
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

Nice To Haves

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

Responsibilities

Expected to work primarily in collaboration with others with some independent work.
Works under general supervision to meet project goals.
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.
Presents 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.
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.