cGMP Consulting

cGMP Consulting is seeking an experienced and driven individual to lead and manage multiple high-impact projects, including validation and qualification activities for equipment, utilities, facilities, systems and processes. This senior-level role offers significant autonomy, leadership responsibility, and the opportunity to influence operations in a fast-paced, GMP-compliant manufacturing environment.

Requirements

• Minimum Bachelors’ degree in Engineering, Science, or a related field of study.
• 5+ 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 multiple 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.

Benefits

• Medical
• Dental
• Vision
• PTO
• 401K