Sr Technical Services Rep
Bloomington, IN
Req ID 51247BR
Business Title
Sr Technical Services Rep
Business
Medical Products
Sub-Business
Manufacturing
Country
US
State/Province
Indiana
Location of Position
Bloomington, IN
Shift_
1st
Job Description
The Senior Technical Services Representative provides technical support to daily Manufacturing operations. The position is visible on the Manufacturing floor, resolves issues during manufacturing and participates in process improvement activities. This position reports to the Manager, Technical Services.
Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned):
•EX1 and EX2 writing without assistance; reviews EX of junior colleagues
•In-depth expertise in aseptic processing, sterilization, cleaning validation,
•Capable of critically evaluating product impact and responsible for advising if product meets release criteria according to all regulatory constraints
•Requires in-depth knowledge of systems and equipment, including: scales, mixing systems and mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends.
•Leads cross-functional improvement teams
•Creates master batch records and determines appropriate equipment set-up parameters for new client projects, scale-ups, and validations for aseptic and challenging formulations and fills; reviews Master Batch Records (MBR) of junior colleagues
•Participates in regulatory, client and internal audits as a product/process Subject Matter Expert (SME)
•Participates independently in client calls and on-site visits to discuss projects and issue resolutions
•Develops and presents in-depth SME courses on pharmaceutical industry topics
Job Requirements
Job Requirements (Education, Experience and Qualifications):
•Bachelors in Engineering, Science, or Pharmaceutical-related field.
•Minimum 3 years experience in a pharmaceutical environment
•Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.) Physical / Safety Requirements:
•Duties may require overtime work, including nights and weekends
•Use of hands and fingers to manipulate office equipment is required
•Position requires sitting for long hours, but may involve walking or standing for periods of time.
•Must be able to qualify for Grade A/B areas.
•Must be able to wear applicable personal protective equipment.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
