Senior Manager, Project Engineering Job in Gaithersburg, Maryland US

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Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc.

Here, you will join passionate professionals who

advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities…that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world.

Title: Senior Manager, Project Engineering

Location: Gaithersburg, MD

Req: 6393

 

Essential Job Functions:

The Process Engineer / Senior Process Engineer will support capital projects as part of a cross-functional team. In addition, this person will be responsible to supporting ongoing operations with technical support to address operational problems as required.

Responsible for establishing technical requirements on capital projects to include:
1. Develops and implements engineering strategy and design that outlines facility and equipment requirements to achieve delivery of network production requirements.
2. Provide technical input and directions during capital project design from concept through detailed design and equipment selection.
a. Identifying initial technical criteria
b. Establishing technical alternatives
c. Leading or supporting development of Basis of Design (BOD)
d. Establishing criteria for selection of A/E service providers and equipment vendors
e. Guiding and monitoring the efforts of service providers during generation of all design deliverables
f. Establishing quality standards for A/E performance and monitoring against those standards

Responsible to support Project Managers during construction to include:
1. Establishing quality standards and benchmarks to monitor construction activities or vendor fabrication
2. Monitoring flow of information between vendors, contractors and internal resources to deliver design intent and meet quality standards
3. Support Project Management during capital project execution addressing technical questions and performing quality checks to ensure successful delivery of the business driver for the project.
4. Support Project Management in delivery of engineering records and turnover packages, training of client staff, and development of operational and maintenance procedures.
5. Support commissioning efforts to deliver a fully qualified project and GMP systems ready for validation.

Responsible to support ongoing development and commercial operations to include:
1. Developing and maintaining an open and positive relationship with appropriate contacts at operational sites
2. Offering technical advice in support of site's requirements.
3. Provides engineering technical on-call support for various process systems including sterile filling equipment, filtrations systems, clean utilities, support equipment such as autoclaves washers, and associated support equipment.

 

Position:
Typical Experience:
Ten years relevant experience in a commercial pharmaceutical sterile fill and finish manufacturing is required. Experience also with the process engineering function of one of the large engineering services firms routinely serving the Biopharmaceutical industry (such as Fluor, Jacobs, Biokinetics, CRB, etc.) would be considered a strong plus.

Education:
Bachelors degree required in Chemical Engineering, Mechanical Engineering, Bio/Chemical Engineering, Biotechnology or related field.

 

Knowledge:

 Technical knowledge of typical sterile fill finish unit operations including filling, filtrations systems, clean utilities, support equipment such as autoclaves washers, and associated support equipment.

 Knowledge of GMP's and regulatory requirements as they relate to equipment and facilities. 

 Must understand the process of technical transfer and how internal process and technical knowledge is used by our outside Engineering firms to drive their own internal project execution processes.

To apply online please click here: 

http://www.candidatecare.com/srccsh/RTI.home?r=2000012668510d=medimmune.candidatecare.com

 

MedImmune is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.

 

MedImmune does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on MedImmune’s approved agency list. Unsolicited resumes or candidate information submitted to MedImmune by search/recruiting agencies not already on MedImmune’s approved agency list shall become the property of MedImmune and if the candidate is subsequently hired by MedImmune, MedImmune shall not owe any fee to the submitting agency.

 

MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.