Job Description

Job Title: Test Methods & Systems Validation Engineer

Location: Indianapolis, IN LTC North - Onsite

Work Type: 12 Month Contract

Pay Rate: $50 $56/hr on W2

About the Role

IQ/OQ/PQ, System Qualification, Test Method Transfer, Test Method Validation, Test Systems, Equipment Qualification, Method Validation, DOE, Statistical Analysis, Technology Transfer, Commissioning, Site Readiness, Validation, Deviations, Change Control, Root Cause Analysis, CAPA, GMP, Technical Documentation, Regulated Manufacturing.

Key Responsibilities

• Support the 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.
• 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.
• Prepare and maintain qualification protocols, validation documentation, engineering reports, procedures, work instructions, and other technical documentation.
• Maintain assigned systems and documentation in a qualified and audit-ready state.
• Support training and knowledge transfer for operators, engineers, manufacturing personnel, and site teams.
• Collaborate with Test Methods Engineering, Project Management, Quality, Manufacturing, Product Stewardship, receiving sites, and external suppliers.
• Support global deployment and technology-transfer activities across manufacturing sites and external partners.
• Travel up to 20% domestically and internationally as required for system deployment, qualification, and method-transfer activities.

Required Qualifications

• Bachelor's degree in Engineering, Engineering Technology, Science, or a related technical discipline .
• 2 5 years of relevant engineering experience in test systems, validation, manufacturing, equipment qualification, or a related technical area.
• Experience with engineering documentation, qualification protocols, validation documentation, and technical reports.
• Ability to analyze technical information and support data-driven engineering activities.
• Strong written and verbal communication skills.
• Ability to manage multiple projects and execute assigned activities independently.
• Ability to work effectively in a regulated manufacturing environment.

Preferred Qualifications

• Experience with IQ/OQ/PQ or equipment/system qualification.
• Experience with test method validation or test method transfer .
• Experience in GMP-regulated manufacturing or another regulated industry.
• Experience with DOE and statistical analysis .
• Experience with commissioning, site readiness, or technology transfer.
• Knowledge of deviation management, CAPA, change control, and root cause analysis .
• Experience supporting manufacturing test equipment or automated test systems.

Regards,

Karthik Mulka

Lead - TA

Phone: 908-905-2354

Email: karthik.m@intellectt.com

Website:

Address 517 Route 1 South, Suite 2103, Iselin, NJ 08830, USA

Equal Employment Opportunity

Intellectt Inc. is committed to providing equal employment opportunities to qualified applicants and employees. Employment decisions are made based on job-related qualifications, skills, experience, and business requirements, consistent with applicable federal, state, and local laws.

We encourage qualified individuals to apply. If you require a reasonable accommodation during the application or hiring process, please contact us to discuss your needs.

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