Principal Engineer

Baxter Bloomington , IN 47406

Posted 3 weeks ago

Principal Engineer

Req #: JR - 017841

Location: Bloomington, IN US

Job Category: Engineering

Date Posted: 3/6/2020 4:35:42 PM

Baxter International

Are you looking for a career that matters?

We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We're looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.

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 from 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 engineering team at the Bloomington facility is responsible for the equipment, facilities, and utilities at our filling, finishing, and warehouse complexes. The team operates cross functionally and practice/promote a hands-on approach. The key functions supported by the engineering team include:

  • Projects
  • Managing all aspects including specification, budgeting, procurement, scheduling, installation, and validation. Projects range from upgrades and repairs to turnkey systems.
  • Facility & Manufacturing Support
  • Mechanical/Electrical/Automation troubleshooting, set-up support, and continuous improvement
  • Validations
  • Authoring & execution of equipment IQs/OQs & validation maintenance
  • Events/NCRs
  • Investigations/root cause analysis and authorship
  • CAPAs
  • Authoring and managing the corrective/preventive actions
  • Work Orders & Change Controls
  • Owning, authoring and ensuring all procedures are followed to maintain equipment in a validated state
  • Regulatory Support: Provides subject matter expertise (SME) to support regulatory, client, and internal audits

As part of the engineering team, the Principle Engineer will lead a team of fellow engineers to provide support for the plant manufacturing equipment & support utilities with troubleshooting, continuous improvement, NCRs/CAPAs, small projects/upgrades, and compliance support. The team will provide day-to-day and emergency (off-hours) support to our Facility & Manufacturing Maintenance teams.

Key attributes for a qualified candidate include:

  • Experienced at mentoring and leading others

  • Displays strong technical expertise with manufacturing equipment & utility systems

  • Capable of multitasking, prioritizing tasks, managing timelines for a team

  • Strong knowledge of regulations and experience presenting to auditors

  • Requires minimal guidance and is considered a self-starter

  • Promotes a 'Team Culture' by supporting the work of other engineers and departments

  • Has experience in Lean principles, VIPs, Kaizen, Standard Work, 5S/6S is preferred

Job Requirements (Education, Experience and Qualifications):

  • Bachelor's degree in engineering

  • Minimum of 5 years' Engineering experience in a Pharmaceutical Environment

  • Validation (IQ/OQ), Investigation (NCR/Event/Deviation), and CAPA experience

  • Prior experience working in an aseptic manufacturing area is preferred

  • 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 will require occasional 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 and let us know the nature of your request along with your contact information.

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