Position SummarycGMP 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.
ResponsibilitiesThe 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.
- 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.
- 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.
- 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.
- Perform additional tasks or duties as assigned by management.
Requirements- 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., Temptales, Kaye, etc.).
- Advanced critical thinking and technical writing skills.
- Strong organizational, communication, and interpersonal skills.
Compensation and Benefits- Expected pay range per year: $75,000-$95,000 USD
- Expected benefits include: Medical, Dental, Vision, PTO, 401K
DisclaimerThe 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.
