Pharma Quality Validation Engineer — IQ/OQ/PQ Expert

Evolving Solution Services; Mount Prospect (IL); On-site; USD 100,000 - 115,000; Full time

Job summary

Xttrium Laboratories in Mount Prospect, IL is seeking a Quality Engineer to support state-of-the-art pharmaceutical manufacturing through rigorous equipment validation activities.

You will develop and review IQ/OQ/PQ protocols, lead FATs/SATs, ensure cross-functional alignment with QA, regulatory, and production teams, and onboard new equipment into quality system.

The ideal candidate has 3-5 years of validation experience, strong documentation skills, and knowledge of FDA/ISO standards.

Qualifications

• Bachelor’s degree in Engineering or related field.
• 3-5 years of experience in validation within a pharmaceutical manufacturing environment.
• Strong understanding of URS, IQ, OQ, PQ documentation.
• Familiarity with regulatory standards (FDA, ISO).

Responsibilities

• Develop and design detailed validation documents, including URS, IQ, OQ, PQ, and process validation protocols.
• Conduct comprehensive process validations and facility qualifications to ensure manufacturing processes adhere to company and regulatory standards.
• Lead cleaning validation efforts to ensure equipment cleaning processes meet regulatory and company standards for preventing cross-contamination and maintaining product integrity.
• Oversee facility qualification activities, ensuring all equipment and infrastructure meet necessary requirements and comply with validation standards.
• Draft and finalize validation reports, summarizing the results of tests, inspections, and data analyses to support quality and compliance efforts.
• Work closely with production, quality control, and regulatory teams to ensure all validation efforts align with regulatory standards and company policies.
• Familiarity with pharmaceutical regulatory requirements and standards (e.g., FDA, ISO).

Skills

IQ/OQ/PQ validation

Technical documentation

Regulatory compliance

Education

Bachelor’s degree in Engineering or related field

Tools

Computer systems validation

Job description

Xttrium Laboratories in Mount Prospect, IL is seeking a Quality Engineer to support state-of-the-art pharmaceutical manufacturing through rigorous equipment validation activities.

You will develop and review IQ/OQ/PQ protocols, lead FATs/SATs, ensure cross-functional alignment with QA, regulatory, and production teams, and onboard new equipment into quality system.

The ideal candidate has 3-5 years of validation experience, strong documentation skills, and knowledge of FDA/ISO standards.