Test Validation Engineering

At cGMP Consulting, we specialize in providing expert validation, qualification, and compliance services to the life sciences industry. Our team works with clients to ensure their facilities, equipment, and processes meet regulatory standards, enabling the safe and efficient production of pharmaceuticals. cGMP Consulting is seeking a motivated and detail-oriented individual to lead sterilization and autoclave validation activities within a GMP-compliant manufacturing environment. This mid-level role offers leadership and responsibility for qualification projects from planning through execution. The ideal candidate will excel in leading cross-functional collaboration, troubleshooting, change management, and protocol completion while demonstrating independence. This candidate should have a strong understanding of current Good Manufacturing Practices (cGMP) and FDA regulations and guidelines.

Author specifications and supporting documentation (URS, RA, FS) for new processes, equipment, and/or systems

Perform activities related to scoping, executing, and managing engineering projects involving facility modifications equipment upgrades, or process improvements

Lead equipment commissioning testing in collaboration with Engineering for new equipment

Develop and qualify autoclave sterilization cycles, including load pattern qualification, to ensure consistent and effective sterilization performance

Execute performance qualification (PQ) studies utilizing biological indicators to verify sterilization efficacy and process reliability

Lead cross-functional team meetings, including preparing agendas and documenting meeting notes. Assist in project forecasting and effectively plan requirements for upcoming tasks

Collaborate with process experts and production personnel to identify and resolve technical challenges

Provide technical expertise and recommend process improvements

Draft change controls and deviations to address failures during qualification activities

Author SOP updates related to CAPA implementation

Maintain compliance with company policies, training requirements, cGMP standards, and safety protocols

Utilize Word, Excel, Document Management Systems, and other electronic tools to complete tasks efficiently

Bachelors’ degree in Engineering, Science, or a related field of study

2-5 years’ experience in a GMP manufacturing environment, including drafting standard operating procedures, protocols, and/or reports. Must be familiar with regulatory (FDA) requirements

Hands-on experience with temperature validation equipment (e.g., Advanced critical thinking and technical writing skills

Medical, Dental, Vision, PTO, 401K

All duties and responsibilities are subject to possible modification to reasonably accommodate individuals with disabilities.