Validation Engineer

Job Location and Salary

Birmingham, AL $65,000.00-$80,000.00 (posted 2 weeks ago)

• Develop URS, SIC and SRA for new and existing aseptic facilities and equipment.
• Develop and execute Commissioning (COM) and Installation qualification (IQ) protocols to ensure systems are installed correctly and according to specifications.
• Perform operational qualification (OQ) and performance qualification (PQ) activities to verify systems operate as intended under all conditions.
• Ensure all documentation is compliant with regulatory requirements and internal quality standards.
• Conduct risk assessments and implement mitigation strategies for aseptic processes.
• Work independently or within a team environment, collaborating closely with other work groups to complete projects on time.
• Effective written and verbal communication skills; clearly communicate observations and outcomes to all employee levels within the company.
• Proficient in word processing, spreadsheet, and presentation software programs; also proficient in Kaye Validator AVS and Val Probe Systems.
• Knowledge of equipment qualifications: homogenizers, pump skids, SIP & CIP skids, temperature control units, tanks, requalification of CTU's.
• Develop and implement validation plans for computerized systems, ensuring compliance with regulatory standards and internal policies.
• Conduct risk assessments to identify potential issues related to system functionality and data integrity.
• Create and maintain comprehensive documentation, including system classification, system overview, test scripts, and reports that demonstrate regulatory compliance.
• Execute CSV protocol to verify systems function as intended.
• Strong problem‑solving and critical‑thinking skills, with the ability to conduct technical programs and achieve program goals; strong organizational skills to handle and delegate multiple projects at varying levels of complexity.
• Excellent interpersonal skills.
• Comprehensive knowledge of pharmaceutical manufacturing equipment and processes.

• Bachelor's degree preferably in Engineering or Science discipline.
• 3–5 years experience in validation/qualification of aseptic pharmaceutical processes and/or equipment.
• Strong understanding of regulatory guidance (FDA/EU), industry best practices, and GMPs.

Associate

Contract

Pharmaceutical Manufacturing