Validation Engineer

Position: Validation Engineer

Location: Chicago, IL 60618

Duration: 6-12 Month Contract

I am looking for an experienced Validation Engineer to join our Sterling Engineering team ensuring that equipment and systems meet all regulatory, quality, and operational standards.

You will be responsible for developing and executing validation documentation in the support of manufacturing systems. This could include manufacturing equipment, lab equipment, facilities, utilities, processes, and/or cleaning qualification and validation.

This position requires expertise in equipment validation, strong technical skills, and knowledge of FDA and ISO regulations.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment used in the production of medical devices.
• Perform equipment qualification activities, including installation, operational, and performance qualifications.
• Review and analyze data from validation studies to ensure compliance with industry standards and internal requirements.
• Collaborate with cross-functional teams, including quality assurance, production, and engineering, to ensure alignment with validation activities.
• Author and maintain validation documentation, including validation plans, reports, and standard operating procedures (SOPs).
• Conduct risk assessments and develop mitigation strategies as needed.
• Ensure compliance with FDA regulations (21 CFR Part 820) and ISO 13485 standards.
• Provide support during internal and external audits by presenting validation documentation and addressing auditor inquiries.
• Troubleshoot and resolve equipment-related validation issues.

Qualifications

• Bachelor of Science degree in Engineering, Life Sciences, or a related field.
• Minimum of 3-5 years of experience in equipment validation within the medical device or pharmaceutical industry.
• In-depth knowledge of validation principles, including IQ/OQ/PQ, and regulatory requirements (FDA, ISO 13485, etc.).
• Strong technical understanding of manufacturing and laboratory equipment.
• Proficiency in developing and executing validation protocols and reports.
• Familiarity with risk management tools such as FMEA.
• Excellent written and verbal communication skills.
• Detail-oriented with strong analytical and problem-solving abilities.
• Ability to work effectively in a team-oriented, fast-paced environment.

About us…Sterling Engineering…we offer FULL BENEFITS! As a Sterling Engineering W2 employee on contract, you are eligible to 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.