Principal Quality Testing Engineer

Responsibilities

• Lead the strategy for method validation, verification, and transfer, including authoring related protocols.
• Mentor QC Analysts in creating and executing method validation, verification, and transfer protocols.
• Coordinate with vendors to identify and evaluate analytical techniques and instrumentation for product/analyte characterization.
• Gather and assess vendor information on costs, installation, calibration, and maintenance for new equipment supporting method validation, verification, or transfer. May author Standard Operating Procedures for new instruments/software.
• Ensure operational compliance with US and international regulatory agencies and guidelines (e.g., FDA, EP, HC, TGA, PIC/S, ISO, USP, NRC, cGMP).
• Author Change Controls, Protocols, Corrective and Preventive Action items, and Periodic Reviews, ensuring compliance with department training and qualification.
• Safely work with radioactivity, ensuring direct reports maintain ALARA and manage daily activities to meet quarterly ALARA goals.
• Provide technical counsel on the scientific content of methods, analytical testing of samples, evaluation and interpretation of laboratory results, and other QC-related issues as required.
• Author Change Controls in Quality Management systems.
• Assist laboratory personnel with instrument repair, troubleshooting, qualification and validation, and training.

Requirements

• Bachelor of Science Degree in Chemistry or a related field is required.
• Eight or more years of relevant experience is required.
• Extensive knowledge of laboratory instruments/methods such as HPLC, GC, IC, ICP-MS, FTIR, UV, and wet bench methods.
• Lean Leader/Operational Excellence/5S experience preferred.
• Proficiency with Root Cause Analysis tools (e.g., Fishbone, 5 Why, Is/Is Not) preferred.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to Relocate:

• Indianapolis, IN: Relocate before starting work (Required)

Work Location: In person