IDM Test Methods & Systems Engineering

Hello,

I hope you're doing well.

My name is Soundarya, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for an IDM Test Methods & Systems Engineering based in Indianapolis, IN with one of our prestigious clients. I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at soundarya.kondra@intellectt.com

Job Title: IDM Test Methods & Systems Engineering
Location: Indianapolis, IN
Work Arrangement: Onsite
Experience Level: 2 5 Years

Job Description:

• Support transfer, installation, qualification, deployment, and maintenance of manufacturing test systems.
• Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.
• Support test method transfers between manufacturing sites and external manufacturing partners.
• Execute test method validation, verification studies, and qualification protocols.
• Support commissioning, equipment startup, site readiness, and test system implementation activities.
• Perform Design of Experiments (DOE), statistical analysis, and technical evaluations.
• Support lifecycle management and sustainment of test methods and test systems.
• Troubleshoot test equipment, test systems, and test method-related issues.
• Support equipment maintenance, periodic reviews, system assessments, and continuous improvement activities.
• Support deviation investigations, root cause analysis, corrective actions, and change implementation.
• Develop and maintain qualification protocols, validation documentation, engineering reports, procedures, work instructions, and technical documentation.
• Maintain assigned systems and documentation in a state of qualification and audit readiness.
• Support training and knowledge transfer for operators, engineers, and manufacturing/site personnel.
• Coordinate with Test Methods Engineering, Project Management, Quality, Manufacturing, Product Stewardship, receiving sites, and external suppliers.
• Support global deployment and transfer activities across manufacturing sites and external partners.
• Travel up to 20% domestically and internationally to support system deployment, qualification, and method-transfer activities.

Minimum Qualifications:

• Bachelor's degree in Engineering, Engineering Technology, Science, or related technical discipline.
• 2 5 years of relevant engineering experience.
• Hands-on experience with engineering documentation, qualification protocols, validation documentation, and technical reports.
• Strong written and verbal communication skills.
• Ability to independently execute activities while supporting multiple projects.

Highly Preferred Experience:

• System/equipment qualification IQ/OQ/PQ
• Test method transfer and/or technology transfer
• Test method development, validation, or verification
• Test system deployment and sustainment
• Analytical testing equipment
• DOE and statistical analysis
• Pharmaceutical, medical device, biotechnology, or other regulated manufacturing environments
• GMP/quality systems
• Deviations, investigations, CAPA, and change control
• Commissioning and manufacturing site readiness
• Technical writing and validation documentation