Job Description
Job Description
About Us
At cGMP Consulting, we specialize in providing expert validation, qualification, and compliance services to the life sciences industry. Out 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 lead projects, including engineering activities for equipment, utilities, facilities, systems, and processes. This mid-level role offers leadership and responsibility in a dynamic, GMP-compliant manufacturing environment.
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 understand 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.
- 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.
- Conduct validation/qualification studies for utility systems, equipment, cleaning, processes, computer systems, and new products. This includes protocol preparation, execution, and final report documentation.
- 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.
- Program and operate analytical instruments (e.g., temperature/humidity dataloggers) for controlled temperature/humidity chamber qualifications, such as lyophilizers, warehouses, sterilizers, and incubators.
- 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.
- 2-4 years’ experience in a GMP manufacturing environment, including drafting standard operating procedures, protocols, and/or reports. Must be familiar with regulatory (FDA) requirements.
- Expertise in one or more of the following areas: cleaning validation, qualification of aseptic filling or formulation equipment/processes, qualification of component preparation equipment/processes, and packaging.
- 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
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.
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