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

MedImmune, LLC

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Location:
Gaithersburg, MD
Posted Date:
9/21/2017
Position Type:
Full time
Job Code:
R-007038
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Location:
Gaithersburg, Maryland, United States
Job reference: R-007038
Posted date: Aug. 18, 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 an Engineer II/Sr. Engineer, 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.  Responsible for maintaining reliable equipment performance for multiple manufacturing processes at MedImmune’s Gaithersburg Clinical Manufacturing facilities including cell culture, purification, and support systems.

Subject Matter Expert (SME) on multiple Biotech manufacturing processes and equipment

Resolves daily operational issues for multiple manufacturing processes

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.  Develops training plans.  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.

EDUCATION

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

EXPERIENCE

Engineer II:         4-years engineering experience including 3-years of GMP experience in a biotech or sterile pharmaceutical manufacturing environment.  Experience with project management, change management, and investigations a plus.

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.

Requirements

REQUIRED SKILLS:

•             Previous experience with operating and/or maintaining biotech manufacturing equipment

•             GMP change management experience and project management experience

•             Good oral and written communication skill, and good interpersonal skills

DESIRED SKILLS:

•             Good at trouble shooting and problem solving. 

•             Hands on mechanical, electrical and/or electronic skills

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

*LI-MEDI

~BSP

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.