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 Senior Quality Engineer in Boulder, CO, 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
As a Senior Quality Engineer, you will provide quality representation for the startup and operation of the Boulder Manufacturing Facility, focusing on automated and computerized systems. You will be involved in review and approval of validation lifecycle documentation, procedures, change controls, deviations and corrective and preventative actions related to manufacturing and engineering operations to ensure products manufactured meet AstraZeneca standards.
You will serve as QA for reviewing documentation for automated manufacturing, utility and facility equipment. You'll be responsible for providing guidance on validating automated and computerized systems, current FDA and EU expectations for Data Integrity and related Part 11 compliance, and efficient implementation of those requirements. Utilize your understanding of PLC and SCADA based automation of biologics manufacturing equipment, and industry requirements for designing, validating, and maintaining those systems to help teams implement effective and compliant solutions. You'll also interpret regulatory requirements and implement quality procedures, administer quality systems, assist in facilitating regulatory compliance inspections and support relevant supplier audits. You will need to understand the validation lifecycle, especially as applied to drug substance manufacture. You will work in a matrixed, cross functional environment and need to effectively communicate quality requirements and the associated rational for those requirements 1 on 1, in team meetings, and with management to achieve the best outcome for patients and the company.
The Senior Quality Engineer will have experience evaluating procedures, change controls, deviation investigations, and validation documents for completeness and compliance with regulatory guidance and company procedures. You'll have the ability to identify root cause and develop corrective actions using tools such as DMAIC. Experience improving work flows through use of tools such as Lean and 6-sigma is desired. You will also be experienced with the use of risk assessments and application of risk based approaches to complex projects or programs.
Bachelor’s degree in engineering, science or math fields of study
Ten years of experience with five to seven years in a regulated GxP environment
Excellent verbal and written skills
Strong project management skills
- Experience in bio-pharma quality
- Experience with Trackwise systems
- Experience interacting with regulators
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