Quality Engineer

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

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Quality Engineer

Full Time Mount Prospect, IL, US

3 days ago Requisition ID: 1014

Our Solutions Protect Patients!

Founded in 1932, Xttrium Laboratories has been dedicated to promoting health and well-being through high-quality products. Recognized as a trusted supplier of disinfectants to hospitals and healthcare providers, Xttrium has expanded its offerings to pharmacies nationwide. With over 40 years of expertise in manufacturing FDA-registered healthcare solutions, the company is a leader in ensuring safety and quality in a health-conscious world.

We are seeking a skilled and detail-oriented Quality Validation Engineer to assist with equipment validations in pharmaceutical manufacturing. The successful candidate will ensure compliance with industry regulations by executing and overseeing equipment qualification processes, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), Cleaning Commissions, and Cleaning Validations. Additionally, this individual will be responsible for onboarding new equipment into the quality system. The role focuses on creating, reviewing, and executing validation documents and protocols to ensure our manufacturing processes and facilities meet the highest quality standards.

Responsibilities

• Develop and design detailed validation documents, including User Requirements Specifications (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.
• Bachelor’s degree in Engineering, Validation, or a related field within chemistry, biology, physics, etc.
• 3-5 years of experience in validation within a pharmaceutical manufacturing environment.
• Strong understanding of validation protocols and documentation, including URS, IQ, OQ, PQ.
• Excellent written and verbal communication skills, with experience writing clear, concise reports.
• Familiarity with pharmaceutical regulatory requirements and standards (e.g., FDA, ISO).

Additional Skills & Qualifications

• Experience with compounding and packaging of liquid drug products (highly preferred).
• Experience with validation of computer systems (preferred).
• Experience with serialization (preferred).

We are proud to be an Equal Opportunity Employer. We welcome people of all backgrounds, experiences, and perspectives. Employment decisions are made based on skills, qualifications, and potential; never on race, color, religion, sex, national origin, age, disability, veteran status, or any other protected trait.

Expected compensation for this role will be between $100,000 and 115,000 on a full-time basis plus applicable health and ancillary benefits offered by the company. Actual compensation will range depending on a number of factors.