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 Process Engineer III 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
The Process Engineer III will start in January 2017.
You will be responsible for providing equipment engineering support of biopharmaceutical manufacturing equipment at AstraZeneca/MedImmune's Boulder Manufacturing Facility. You will primarily be responsible for reliability and readiness of process equipment and systems such as bioreactors, media prep, media hold, inoculum prep, UF/DF, high pressure liquid chromatography, viral filtration, centrifugation, buffer prep & hold, bulk formulation & filtration. Potential support of harvest equipment may be required which includes tanks, centrifuges, and harvest filtration skids, cleaning equipment and other support systems such as CIP, COP, GMP washers, and autoclaves.
Your core responsibilities will include resolving technical issues with the equipment as it pertains to the process requirements, optimizing and improving the process equipment, identifying root causes for deviations, defining corrective and preventative actions and implementing new or replacement equipment as required. You will lead Validated System Change Requests (VSCRs) associated with the equipment or systems. You will be expected to possess strong technical skills and experience with biopharmaceutical unit operations and equipment. You will also be called upon to represent the cleaning systems to regulatory inspections or audits.
- Bachelor's Degree in Engineering or Life Sciences
- Five to ten years of experience in a cGMP or other regulated industry
- Extensive knowledge of process engineering to provide support for manufacturing equipment and the associated controls, including common issues and performance indicators
- Experience supporting and troubleshooting equipment issues, and assisting to resolve cleaning issues
- Ability to apply engineering theory to equipment issues, projects, and improvement ideas
- Experience developing preventative and predictive maintenance plans for process systems to ensure highest reliability and efficiency
- Ability to develop procedures for operating and maintaining process equipment
- Ability to prioritize, plan, and manage multiple tasks and projects
- Experience participating in or leading process investigations and regulatory inspections
- Experience supporting or leading process equipment validation and SIP qualifications
- Experience supporting or leading FAT, SAT, commissioning, and qualification activities for new or modified systems
- Experience in biotech/pharmaceutical
- Knowledge of cell culture, purification and/or CIP operations
- Experience with GMP change control and nonconformance investigations
- Understanding of controls systems (PLC, SCADA, BMS)
- Working knowledge or experience with: Upstream cell culture processes and systems such as bioreactors, media prep, media hold, and inoculum prep OR Downstream commercial scale high pressure liquid chromatography
- USP Specifications for clean water systems.
- Experience working with or supporting autoclaves, dispensing equipment, bioreactors, and other process equipment.
- Experience supporting or leading cleaning validation.
- Experience supporting and troubleshooting CIP systems, cleaning circuits, and skids
- Experience developing CIP circuits for new or modified equipment systems
- Understanding or working knowledge of RCM (Reliability Centered Maintenance) principles
- Thorough understanding of cGMP's and how they relate to cleaning of process equipment.
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