Sr. Engineer / Manager, Biotech Manufacturing - Gaithersburg, MD | Biospace
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Sr. Engineer / Manager, Biotech Manufacturing

MedImmune, LLC

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

Job Description

                                       Location:Gaithersburg, Maryland, United States
Job reference: R-007038

Posted date: May. 08, 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 Sr. Engineer/Manager, Biotech Manufacturingin Gaithersburg, 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.

This position reports to the Associate Director of Engineering Technical Services supporting GMP clinical manufacturing.  This position will be a Senior Engineering role with both individual contributor and managerialresponsibilities.
Responsible for maintaining reliable equipment performance for multiple manufacturing processes at MedImmune’s Gaithersburg Clinical Manufacturing facilities including cell culture, purification, and support systems.  Responsible for metrics tracking, and managing the ETS training program, interns, and up to two FTEs (depending on experience and qualifications).



Subject Matter Expert (SME) on multiple Biotech manufacturing processes and equipment. Resolves daily operational issues for multiple manufacturingprocesses.  Performs
troubleshooting, maintenance, and process performance optimization. Installs or replaces components and equipment.  Leads shutdown and return to service activities.   Writes, tracks, and executes SAP work orders. Creates and revises Preventative Maintenance plans. Coordinates maintenance activities with Facilities. Coordinates service contracts and work of outside vendors.  Leads cross functional teams, FTEs and contractors. Obtains quotes and purchases spare parts and equipment, and adds parts to the SAP inventory system. Monitors equipment performance.  Identifies equipment issues and engineers potential solutions. Determines process requirements.  Designs, installs, and commissions new processes and equipment.  Writes cGMP documentation (SOPs, MPRs, protocols, etc.).  Writes other documentation including: user requirements, specifications, protocols, HECPs, drawings, and reports. Leads and participates in quality/safety investigations, and risk evaluations.  Owns and executes Quality and Safety CAPAs.  Performs complex GMP change control activities.  Approves equipment validation and change control documents.  Instructs staff on process/system integration and operation.  Manages ETS training and the ETS apprentice program.  Mentors more junior staff. Develops new engineering projects.  Creates project scopes, URS, and timelines.  Represents Manufacturing and Engineering Services on equipment projects managed by other engineering groups. Reviews specifications, work instructions, protocols, drawings, and reports for technical accuracy. Evaluates new equipment technologies.  Participates in tech transfers. Provides on-call support and works overtime as needed.



Bachelor’s degree in Engineering (Chemical Engineering preferred) or Life Sciences.



Senior Engineer-  8 years engineering experience including 6-years of GMP experience in a biotech or sterile pharmaceutical manufacturing environment.  4-years of project management experience, change management, and investigation experience required.  Experience with budgeting, presentations to upper management, and/or compliance audits a plus.


Manager-11 years engineering experience including 8-years of GMP experience in a biotech or sterile pharmaceutical manufacturing environment.  7-years of project management experience, change management, and investigation experience required.  Experience with budgeting, presentations to upper management, and/or compliance audits a plus.  Prior supervisory / management experience a plus.



Previous experience with operating and/or maintaining upstream biotech manufacturing equipment, includingbioreactors/fermentors,
CIP skids, andcentrifuges.  


GMP change management experience and project management experience


Good oral and  written communication skills, and good interpersonal skills



Good at trouble shooting and problem solving.


Hands on mechanical, electrical and/or electronic skills


Experience with automated process control systems (PLC / SCADA).




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.


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