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.

Job Description

This position is responsible for supporting the calibration of production equipment in a GMP facility, while ensuring compliance with FDA regulatory standards and GMP requirements. This individual will support the metrology technicians, revise and develop calibration procedures, and maintain documentation related to equipment qualification and validation.  

cGMP Consulting is looking for an individual who is efficient, comfortable working independently, and who will handle multiple projects and priorities, work with tight deadlines, address high priority requests, and effectively lead and manage multiple projects to completion. The ideal candidate for this job is resourceful, independent, organized, and capable of working in a fast-paced environment.

Responsibilities

• Perform activities pertaining to calibrations, routine inspections, testing and repairs of instruments and equipment.
• Utilize knowledge of measurement principles, standards, and methodologies to ensure accurate and reliable measurements across applications.
• Calibrate and verify measurement instruments, ensuring accuracy and performance.
• Troubleshoot measurement issues, identify root causes of deviations, and develop solutions to improve accuracy.
• Actively seek improvement to the metrology processes, techniques and best practices.
• Ensure timely completion of scheduled and demand calibration work orders.
• Perform and remediate all nonconformance issues such as, status reports, bad actors and calibration delinquencies.
• Assist in the selection of the appropriate instruments for intended use.
• Work with client representatives to fully understand needs and solve problems and they arise.
• Ensure safety standards at the client are met and adhere to safe working practices.
• Schedule, lead, and participate in meetings and discussions related to assigned client projects.
• Maintain compliance with company policies, training requirements, cGMP standards, and safety protocols. 
• Perform additional tasks or duties as assigned by management.

Position skills and requirements:

• Minimum 5+ year experience in metrology.
• Applied knowledge of calibration program requirements.
• Knowledge of cGMP, USP and ICH regulations and standards as they pertain to calibration and metrology.
• Experienced with laboratory and production equipment.
• Understanding of equipment validation requirements and process.
• Strong organization and computer skills.
• Highly motivated and independent individual.
• Detail oriented and comfortable working in a fast-paced office environment.
• Exceptional communication and leadership skills.
• Superior organizational, communication, and interpersonal skills are necessary.

Compensation and Benefits 

• Expected pay range per year: $85,000-$105,000 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.