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.

Position Summary

cGMP Consulting is seeking a motivated and detail-oriented individual to support establishing and maintaining the reliable operation and qualified state of formulation equipment. Ensure that equipment is in-control, compliant, and capable of meeting standards, while supporting continuous improvements.  

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: 

• Provide engineering expertise with the process team related to formulation equipment.
• Author specifications and supporting documentation (URS, RA, FS) for new processes, equipment, and/or systems. 
• Review and approve validation documents needed for execution of formulation equipment.
• 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 Validation for new equipment. 
• Conduct engineering studies for utility systems, equipment, cleaning, processes, computer systems, and new products. This includes protocol preparation, execution, and final report documentation.
• 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 and production activities.
• 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. 
• 2-4 years’ experience in a GMP manufacturing environment specifically with formulation equipment. 
• Hands-on experience with troubleshooting issues with production equipment.
• Change Control and/or Deviation drafting and investigation experience.
• Familiar with regulatory (FDA) requirements. 
• Advanced critical thinking and technical writing skills.
• Strong organizational, communication, and interpersonal skills. 

Compensation and Benefits 

• Expected pay range per year: $115,000-$135,000 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.