Validation Engineer

Lumin Innovations; Chicago (IL); On-site; USD 113,000 - 151,000; Full time

Job summary

A leading company in pharmaceutical manufacturing is seeking a Validation Engineer to develop and execute validation protocols, ensuring compliance with cGMP and FDA regulations. The ideal candidate will have a Bachelor's degree in Engineering or Life Sciences and at least 3 years of experience in validation roles. This position offers a competitive salary and opportunities for professional growth in a dynamic environment.

Qualifications

• 3+ years of experience in a validation role within a pharmaceutical or biotechnology environment.
• Strong knowledge of cGMP regulations and FDA guidelines.
• Experience with validation of equipment and manufacturing processes.

Responsibilities

• Develop and execute validation protocols for equipment and processes.
• Collaborate with QA and Engineering to align validation efforts.
• Maintain validation master plans and ensure regulatory compliance.

Skills

Technical writing

Communication

Project management

Education

Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline

Job description

• Develop, author, execute, and review validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment, utilities, cleaning, and manufacturing processes.
• Perform risk assessments, gap analyses, and data reviews to support robust validation and re-validation strategies.
• Ensure that all validation activities are documented and conducted in compliance with cGMP, FDA, and internal procedures.
• Collaborate cross-functionally with Quality Assurance (QA), Manufacturing, Engineering, and other departments to align validation efforts with business and regulatory needs.
• Support investigations and change control activities related to validation and ensure timely closure of associated documentation.
• Maintain validation master plans and ensure alignment with regulatory expectations and industry best practices.
• Participate in audits and inspections, providing validation documentation and subject matter expertise as required.
• Continuously improve validation practices and procedures to enhance compliance and efficiency.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
• 3+ years of experience in a validation role within a pharmaceutical, biotechnology, or medical device manufacturing environment.
• Strong knowledge of cGMP regulations, FDA guidelines, and industry standards such as ASTM E2500 and GAMP 5.
• Experience with validation of equipment, utilities (e.g., HVAC, purified water), cleaning, and manufacturing processes.
• Excellent technical writing, communication, and project management skills.
• Ability to work independently and collaboratively in a fast-paced, regulated environment.

Preferred Qualifications:

• Experience with computer system validation (CSV) is a plus.
• Familiarity with quality systems, change control, deviation management, and CAPA processes.
• Advanced degree or certifications (e.g., CQE, CQA) are advantageous.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

• Industries

  Pharmaceutical Manufacturing

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