Sr Validation Engineer

AstraZeneca•Gaithersburg, MD

22h•Onsite

About The Position

Do you have a passion for Science ? Would you like to apply your expertise to impact a company that follows science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you! At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. About AstraZeneca in Gaithersburg, MD : Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world . This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration. The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you’ll find newly-designed , activity-based work spaces to suit a variety of working styles while increasing collaboration between teams . J oin our dynamic Site Validation team as a Sr Validation Engineer. The department supports all areas of clinical manufacturing including support laboratories.    The areas of accountability include equipment, utilities and facilities validation, CVS and daily operational support.   The multiple areas of accountability create a wealth of diversity and growth opportunities for anyone interested in expertise in quality engineering .

Requirements

Bachelor's degree in engineering or sciences with 3 + years of experience , master's degree in engineering or science with 2 + years' experience , PhD Degree in Engineering or Science with 1 + years' experience or HS Diploma with 8 + years' experience .
Demonstrated technical writing skills.
Possesses excellent organization and interpersonal skills.
Ability to work effectively in teams and foster collaborative relationships.
Demonstrates strong communication and facilitation skills
Bachelor’s degree in engineering or sciences or equivalent with 5 + years of experience .

Nice To Haves

GMP experience in a pharmaceutical or biotech manufacturing environment
Operational experience with analytical or manufacturing systems
Qualification, validation or general testing experience
Project management experience including creation of project plans.
Issue Resolution / management of change

Responsibilities

Execute system validations for Manufacturing, Analytical and CTUs for all functions supporting the Gaithersburg Pilot Facility including Manufacturing, Analytical Sciences, Quality Control, Facilities, and Device functions.
Manage validation lifecycle including execution of revalidations and periodic system review.
Manage the CVS program and execute routine CVS
Author validation protocols, reports, SOPs and other technical documents in support of the validation program at AstraZeneca.
Executes data integrity assessments to ensure proper data generation and security for cGMP systems.
Assists in performing project management activities.
Support AstraZeneca’s Audit and Inspection Program.

Benefits

fitness center
employee healthcare clinic
electric vehicle charging stations
dry cleaning
full-service cafeteria
copy center
qualified retirement program [401(k) plan]
paid vacation and holidays
paid leaves
health benefits including medical, prescription drug, dental, and vision coverage