Quality Process Engineer/Senior Quality Process Engineer - (Frederick, MD) - Frederick, MD | Biospace
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Quality Process Engineer/Senior Quality Process Engineer - (Frederick, MD)

MedImmune, LLC

Frederick, MD
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

                                       Location:Frederick, Maryland, United States
Job reference: R-003001

Posted date: Jan. 19, 2017



   If you’re inspired by the possibilities of science to change lives and you thrive when making brave decisions – join us.  

   MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease.  As a Quality Process Engineer/Senior Quality Process Engineer in Frederick, MD, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.  

   We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.  

   MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.  

   Main Duties and Responsibilities  

  •      You will provide Quality support for product and process tech transfers and be responsible for the review and approval of Tech Transfer and Re-Introduction project documentation, such as Facility Fit reports and Master Batch Documentation.
  •      You will be responsible for ensuring that GMP operations are being conducted according to internal and external quality requirements.  
  •      You will be responsible for leading quality system continuous improvement initiatives as well as interfacing with other functional areas including manufacturing, facilities, QC, and other Quality departments to oversee activities.
  •      You will review and approve documents and records such as SOPs, deviations, change control requests, corrective and preventive action plans, validation protocols/reports, technical reports, etc., to ensure fulfillment of quality and compliance related requirements.    


   Essential Requirements  

   Minimum requirements:  

   Bachelor's degree Sciences/Engineering with five years' work experience in biopharmaceutical/pharmaceutical industry or Master's Degree Sciences/Engineering with 3 years' work experience in biopharmaceutical/pharmaceutical industry.  

   Desirable Requirements  

  •      Well versed in validation practices and their application in the biopharmaceutical environment.
  •      Solid operating skills including; timely decisions, managing and measuring work, and excellent time and project management skills.    
  •      Ability to perform risk assessments which results in an overall improvement in consistency and risk awareness.    
  •      Ability to effectively utilize Project management tools.    
  •      Ability to generate and communicate/document process and product knowledge and translate into solutions to complex or ambiguous issues.    
  •      Ability to interpret regulatory requirements and implement quality procedures, administer quality systems, assist in facilitating regulatory compliance inspections and support relevant supplier audits.    

   Next Steps – Apply today!  


   To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.  

   AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.