Process Validation Scientist

Company: myGwork
Location: Fargo
Posted on: August 7, 2022

Job Description:

Aldevron is an industry pioneer with a core competency in manufacturing for gene and cell therapy. We supply high-quality plasmid DNA, mRNA and proteins to our clients, who are breaking new ground on the world's most important and challenging solutions to benefit us all. We're looking for innovative, forward-thinking individuals who share our goals of advancing science and making an impact on the world. Aldevron is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we're pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives. The role of the Process Validation Scientist I will be to support internal and external Process Validation and Robustness activities with projects focused on understanding and reducing process variability to improve product quality, cost, and process efficiency. Additional responsibilities include supporting Cleaning Validation and Facility Environmental Monitoring Qualifications to ensure the production environment is compliant with regulatory requirements. They will be an active member on cross-functional teams, supporting Aldevron initiatives. Responsibilities:

• Work collaboratively to design, conduct, and report findings on experiments characterizing new or changed manufacturing processes and new equipment or technology.
• Support continuous improvement projects addressing process variability, efficiency, product cost and data analysis.
• Compile, maintain, analyze and make recommendations based on critical data supporting R&D, engineering and validation work.
• Develop, execute and/or coordinate execution of process, cleaning, shipping and continued process verification activities.
• Write and review validation documents related to facilities, cleaning or process validation systems comprising check for compliance with corporate standards, regulatory requirements, and technical expertise. Qualifications:
  • B.A. or B.S. in Biology, Biochemistry, Engineering or related science
  • Minimum 3-5 years of experience in GMP biologics manufacturing
  • Experience with Cleaning Validation, Media Fill Simulation and/or environmental monitoring programs is a plus.
  • Knowledge of regulatory and cGMP regulations for pharmaceutical manufacturing operations, and validation procedures and practices. When you join us, you'll also be joining Danaher's global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization. Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
    
    
    The EEO posters are available here .
    
    
    We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.
    
    
    If you've ever wondered what's within you, there's no better time to find out. When you join us, you'll also be joining Danaher's global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization. Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
    
    
    The EEO posters are available here .
    
    
    We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.
    
    
    If you've ever wondered what's within you, there's no better time to find out. This employer is a corporate member of
    myGwork - LGBTQ+ professionals, the business community for LGBTQ+ professionals,
    students, inclusive employers & anyone who believes in workplace equality.
    

Keywords: myGwork, Fargo , Process Validation Scientist, Other , Fargo, North Dakota