Production Technician III - 10361

Organization
MedImmune
Job Location
Frederick, MD 21703
Benefits

Medical, Dental, Vision, 401K, LTD/STD, etc. 

Job Description

* Manufactures clinical and commercial biologics meeting the regulatory requirements of both domestic and international markets
* Experts and Qualified Trainers in the operation of production equipment in multiple areas in a large scale, automated bioprocess plant such as, bioreactors, centrifuges, virus filtration, depth filtration, tangential flow filtration, chromatography equipment, washers, autoclaves, biological safety cabinets, chemical fume hoods, column packing equipment, and instrumentation pH, conductivity, osmolality, blood gas analyzers, turbidity, etc.
* Accurately analyzes and processes scientific data
* Serves as the "Subject Matter Expert" in unit operation
* Reviews Master Production Records for accuracy and completion of process steps, as requested
* Authors and edits Standard Operating Procedures (SOPs), Master Production Records and Solution Preparation Records
* Responsible for training junior staff
* Mentors others in process operations and domestic and international regulatory compliance
* Routinely monitors manufacturing processes and recognizes potential process issues as they arise; proactively escalates identified issues to senior staff
* Troubleshoots problems and recommends potential solutions to Manufacturing support groups and/or Management
* Contributes to the development of new concepts and techniques
* Leads unit operations or projects, as requested
* Participates in the tech transfer process of new products into the manufacturing area.
* May be cross-trained in multiple areas within Manufacturing
* Identifies and supports the implementation of process efficiencies and areas for improvement

Requirements

* Advanced equipment knowledge to perform first line trouble-shooting and root cause analysis
* Advanced understanding of the general and detailed aspects of the job, and their practical applications to problems and situations commonly encountered
* Advanced knowledge of how to effectively utilize MedImmune's enterprise systems such as:
o SAP
o AEGIS
o ELMS
o Insight
o Microsoft Office
o Delta V
o Trackwise
* Advanced knowledge of cGMP principals and standards
* Sufficient knowledge of process, systems and equipment to troubleshoot problems
* Demonstrates sound scientific knowledge and understanding of manufacturing processes in core area
* Knowledgeable of electronic quality systems
* Knowledgeable of the current Code of Federal Regulations (CFR)

Education/Years of experience:
3-5 yrs experience with Bachelors,
4-6 years' experience with Associates,
7-10 years with High School Diploma
* Preferred: Bachelor's degree in the sciences or engineering and 3-5 years relevant experience

**candidate MUST be willing to work 12hr 6:00 to 6:30 (both AM and PM start times).**

Skills:
* Regularly works on routine manufacturing and other assignments that are very complex in nature, where independent action and a high degree of initiative are required to make recommendations and resolve problems
* Develops solutions to complex problems requiring ingenuity and creativity/innovation.
* Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions.
* Ability to deal with problems involving a few concrete variables in standardized situations.
* Works under minimal supervision
* Initiates routine tasks
* Normally receives no instructions on routine work and general instructions on new assignments
* Adheres to Good Manufacturing Practices (GMP) and standard operating procedures (SOP)
* Interacts regularly with co-workers, senior personnel and supervisor
* Contacts are frequent with individuals representing other department, and/or representing outside organizations.
* Contacts involve obtaining or providing information or data on matters of moderate importance to the function of the department or which may be of sensitive nature, requiring some explanation or interpretation.

How to Apply

Visit https://www.medimmune.com/about-us/careers.html

Click "Explore Opportunities"

Enter '10361' into Req ID

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