Autoclave Validation Engineer

About Us
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 based in Lake Forest main client locations are Melrose Park IL North Chicago IL Waukegan IL and Pleasant Prairie WI.

Position Summary
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.

Responsibilities
The essential functions include but are not limited to the following:

• Author specifications and supporting documentation (URS RA FS) for new processes equipment and/or systems; focusing on autoclaves.
• 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 autoclaves.
• 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.
• Perform temperature mapping studies using Kaye Validators and other analytical instrumentation (e.g. temperature/humidity dataloggers) to support autoclave and sterilizer qualification activities.
• Manage multiple qualification activities while providing deliverable updates and modifications to existing scheduling to support execution activities.
• Lead cross-functional team meetings including preparing agendas and documenting meeting notes. Facilitate follow-up meetings in regard to action items previously identified.
• 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.
• Maintain compliance with company policies training requirements cGMP standards and safety protocols.
• Perform additional tasks or duties as assigned by management.

• Bachelors degree in Engineering Science or a related field of study.
• 2-5 years experience with autoclave validation and temperature mapping(e.g. Temptales Kaye etc.).
• 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.
• Advanced critical thinking and technical writing skills.
• Strong organizational communication and interpersonal skills.

• Expected pay range per year: $75000-$95000 USD
• Expected benefits include: Medical Dental Vision PTO 401K

Disclaimer
The duties and responsibilities described are not a comprehensive list and additional tasks may be assigned to the employee from time to time; or the scope of the job may change as necessitated by business demands. All duties and responsibilities are subject to possible modification to reasonably accommodate individuals with disabilities. The requirements listed are the minimum levels of knowledge skills or abilities necessary to perform this job successfully. The company is an Equal Opportunity Employer drug-free workplace and complies with ADA regulations as applicable.