Quality & Validation Engineer

Title: Quality & Validation Engineer

Location: Des Plaines, Illinois

Duration: 6 Months

Job Summary:

We are seeking a highly motivated Quality & Validation Engineer to support qualification and validation activities within a regulated manufacturing environment. This role will work closely with cross-functional teams to ensure validation programs, manufacturing processes, and quality systems meet internal standards and regulatory requirements. The ideal candidate will have strong experience in validation processes, technical documentation, and regulated industries such as medical devices or pharmaceuticals, with exposure to HPLC synthesis, purification, and testing.

Key Responsibilities:

• Maintain strong collaborative partnerships with cross-functional teams including Quality, Engineering, Manufacturing, and Regulatory to ensure high product quality and compliance.
• Review and support qualification and validation documentation to ensure alignment with company standards and regulatory requirements.
• Participate in the complete validation lifecycle, including equipment, process, test method, and automation validations supporting manufacturing expansion.
• Support the implementation and qualification of new manufacturing FUE (fixtures, utilities, and equipment) and automation systems.
• Contribute to validation activities related to HPLC synthesis, purification, and analytical testing processes.
• Support on-market change control projects, ensuring proper validation and documentation are completed for process or product changes.
• Ensure validation documentation meets FDA, GMP, ISO 13485, and ISO 14971 regulatory requirements.
• Conduct technical reviews of protocols, reports, and validation records to ensure completeness, accuracy, and compliance.
• Support internal and external audits by preparing and presenting validation documentation.
• Provide technical input and recommendations to improve validation processes, quality compliance, and operational efficiency.

Required Qualifications:

• Bachelor’s degree in Life Sciences, Engineering, or a closely related discipline, or an equivalent combination of education and experience.
• Minimum 5 years of experience in Quality, Validation, or a related role within a regulated industry.
• Demonstrated experience supporting validation programs and quality compliance initiatives.
• Strong technical writing and documentation skills.
• Excellent verbal and written communication skills with the ability to work effectively in cross-functional teams.
• Proven track record of successfully completing projects and supporting compliance outcomes.

Preferred Qualifications:

• Bachelor’s or Master’s degree in Chemical, Electrical, Biomedical, or Mechanical Engineering.
• 5+ years of professional experience in Medical Device Quality, Pharmaceutical, or other regulated industries.
• Strong knowledge of FDA regulations, GMP, ISO 13485, and ISO 14971.
• Experience with HPLC synthesis, purification, and analytical testing validation.
• Experience supporting manufacturing expansion, automation validation, and change control processes.

Key Skills:

• Validation & Qualification (IQ/OQ/PQ)
• Process & Test Method Validation
• HPLC & Analytical Testing Support
• GMP / FDA / ISO Compliance
• Change Control & CAPA Support
• Technical Documentation & Reporting
• Cross-Functional Collaboration

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.