Validation Engineer

Position: Validation Engineer

Location: Chicago, IL 60618 onsite daily

Duration: 6-9 months

I am looking for a detail-oriented and experienced 3-5 years - Equipment Validation Engineer to develop and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment used in the production of Class I medical devices. The ideal candidate will have a comprehensive understanding of regulatory requirements, equipment testing methodologies, and risk management tools such as Design Failure Mode and Effects Analysis (DFMEA).

OVERVIEW OF RESPONSIBILITIES

• Author and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for new and existing manufacturing equipment.
• Plan, perform, and document testing activities to verify that equipment operates within defined specifications and consistently produces products that meet quality standards.
• Develop and implement test plans and acceptance criteria in alignment with regulatory guidelines (21 CFR Part 820, ISO 13485).
• Coordinate and perform equipment testing including functionality, alarms, interlocks, safety features, software controls, repeatability, and process capability.
• Analyze and interpret test results, ensuring equipment performance meets user requirements and process parameters.
• Collaborate with Engineering, Manufacturing, and Quality teams to support equipment commissioning and validation efforts.
• Conduct DFMEA to evaluate potential failure modes and their effects on process and product outcomes; implement mitigations as needed.
• Identify and troubleshoot issues uncovered during testing or validation; propose corrective actions and coordinate re-testing as required.
• Maintain comprehensive and compliant validation documentation, including test data, summary reports, and traceability matrices.
• Support ongoing validation lifecycle activities including equipment requalification, change control assessments, and periodic reviews.
• Ensure compliance with the applicable FDA, ISO, and internal quality system requirements.

QUALIFICATIONS

• Bachelor of Science degree in Engineering, Life Sciences, or a related field.
• 3–5 years of experience in equipment validation and testing within a regulated medical device manufacturing environment.
• Strong working knowledge of IQ/OQ/PQ development, execution, and equipment performance testing.
• Proficiency in DFMEA, test method development, and risk-based validation strategies.
• Familiarity with GAMP 5, 21 CFR Part 820, and ISO 13485 requirements.
• Excellent technical writing skills and attention to detail.
• Strong analytical, organizational, and cross-functional communication skills.
• Ability to manage multiple validation projects in a dynamic, fast-paced environment.
• Experience with automated manufacturing, assembly, or packaging equipment is preferred.
• Knowledge of PLC/HMI interfaces, data acquisition systems, and control logic testing.
• Certification in Six Sigma, CQE, or equivalent quality/engineering credentials is preferred.

About us…Sterling Engineering…we offer FULL BENEFITS! As a Sterling Engineering W2 employee on contract, you receive a Full Employee Benefits Package that includes Paid Time Off, Paid Holidays, 3 Medical plans to choose from, Dental & Vision plans, 401(k) with a match, and an Employee Stock Ownership (ESOP) plan.

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.