Sr Principal Engineer
Bloomington, IN
Req ID 50073BR
Business Title
Sr Principal Engineer
Business
Global Quality
Sub-Business
Medical Products Support
Country
US
State/Province
Indiana
Location of Position
Bloomington, IN
Shift_
1st
Job Description
Summary :
The Senior Principal Quality Engineer is responsible for equipment validation, qualification and change control by partnering with cross-functional teams (Engineering, Technical Services, Manufacturing, etc.) to ensure timely execution and approval. This position reports to the Quality Manager II - Engineering.
Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned) :
• Provide guidance and technical expertise of regulatory and Baxter requirements in validation strategies and processes. Assess impact of changes to current Good Manufacturing Practices (cGMP) equipment and systems.
• Quality signatory responsible for providing leadership, guidance and oversight of commissioning, qualifications and validations related to equipment utilized in the manufacturing of pharmaceutical drug products.
• Evaluate internal Quality Systems (change control, preventive maintenance, and spare parts) for efficiencies and execute solution implementation to completion.
• Review and/or approve documentation as required (Project Plans, Master Batch Records, Process Validation protocols, regulatory submissions, Client standard operating procedures).
• Author and/or approve applicable deviation reports for equipment and process related deviations
• Guide peers in the use of statistically-based Quality Engineering approaches in project and test planning and in the analysis and interpretation of test results (e.g. FMEA, DOE, SPC, etc.).
• Mentor others in the areas of Quality Engineering and Quality System regulations.
• Provide leadership role in generating Design Plans, reviewing design inputs, outputs, verification, validation and design transfer strategies.
• Lead Risk Management activities for sustaining engineering projects.
• Lead continuous improvement activities
• Support post market activities such as complaint investigation, complaint trending, site corrective actions and Tier 2 corrective action/preventative action (CAPA).
• Subject matter expert (SME) and key participant in compliance audits and inquiries.
• Provide Quality input to risk remediation activities.
• Plan and lead the analysis, test, verification, inspection, and integration of design to ensure the quality of components and/or products.
Job Requirements
Job Requirements (Education, Experience and Qualifications):
• Bachelor's degree in Engineering required.
• M inimum 8 years of relevant experience required, preferably in Quality Engineering for pharmaceutical, biologics or medical device manufacturing preferred
• American Society of Quality (e.g., CQE, CMQ/OE, etc.) and/or Six Sigma certification 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 wear appropriate personal protective equipment.
• 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.
• Must be able to lift 50 lbs
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.
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