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Project Leader Engineering

Req #: 180003JJ_en
Location: Bloomington, IN US
Job Category: Manufacturing
Date Posted: 2/6/2018 2:11:48 PM
Baxter International

Description

Baxter International Inc. BioPharma Solutions facility in Bloomington is one of the largest contract manufacturing facilities of sterile pharmaceutical products in North America, with a state-of-the-art 600,000 square-foot campus. As a full-service contract manufacturer, our Bloomington facility services client needs with development through commercial launch.  Our facility includes:
  • Facilities/Utilities: Direct and indirect systems such as steam, water, BMS, HVAC
  • Formulation/Fill: Syringe, vial, & cartridge lines in addition to formulation suites
  • Finishing/Packaging: High speed inspection, bulk & unit packaging, serialization
The New Product Introduction (NPI) teams at the Bloomington facility are responsible for onboarding new client products at the site. The teams are cross functional and include members from Program Management, Engineering, Tech Transfer, Supply Chain, and others. The key responsibilities of  a Project Leader in the Engineering Development team includes:
  • Project Evaluation - Provides subject matter expertise (SME) during the evaluation and proposal phases of new projects.  Includes providing input on equipment requirements and cost/timeline estimates.
  • Client Support: Work directly with the client to support the process development and implementation throughout the duration of the project.
  • Project Management – Specification, budgeting, procurement, scheduling, installation, and validation of projects that range in scope from:
      • Line validations for projects utilizing existing equipment
      • Specification/procurement of product contact parts, material handling parts, tanks, instrumentation, and additional support equipment
      • Procurement and fitment of change parts for entire lines
      • Local and client capital projects
  • Development – Introduce new concepts/ideas as needed for unique processes
  • Manufacturing Support – Hand-on troubleshooting and set-up support during demonstration and engineering batches as well as continuous improvement initiatives
  • Work Orders & Change Controls – Owning, authoring and ensuring all procedures are followed to maintain equipment in a validated state
  • Validations – Authoring & execution of equipment IQs/OQs
  • Events/NCRs & CAPAs – Support investigations and implementation of corrective/preventive actions
Key attributes for a qualified candidate for this position include:
  • Capable of multitasking and prioritizing tasks (multiple concurrent projects)
  • Strong communication and interpersonal skills
  • Displays strong technical expertise
  • Requires minimal guidance

Promotes a ‘Team Culture’ by supporting the work of other NPI team members, engineers, and departments

Qualifications

Job Requirements (Education, Experience and Qualifications):
  • Bachelor degree (engineering degree preferred)
  • Minimum 3 years’ experience, including 2 years pharmaceutical experience
  • Pharmaceutical knowledge including GMPs, regulatory requirements, and validation
  • 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:
  • Must be able to lift up to 50lbs
  • Duties may require overtime work, including nights and weekends
  • Use of hands and fingers to manipulate office equipment is required 
  • Position requires sitting or standing for long hours 
  • Must be able to gown qualify for Grade A/B areas

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy

Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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