Senior CQV Consultant: Lead Validation & Commissioning

Quality Agents, LLC; Rockville (MD); Sur place; USD 100 000 - 135 000; Plein temps

Avantages offerts par ce poste

Health insurance

Dental insurance

Vision insurance

Life insurance

AD&D insurance

Disability insurance

HSA

401k

Paid time off

Paid holidays

Parental leave

Bonus potential

Résumé du poste

Quality Agents, LLC seeks a Senior Consultant to lead technical work streams and mentor junior staff in qualification and validation projects for pharmaceutical equipment, utilities, and facilities. You will ensure compliance with cGMP expectations and coordinate with clients on validation strategies.

Travel to client sites is required to support qualification activities and ensure on-time delivery. Strong technical writing and data analysis skills are essential for success in this role.

Qualifications

• BS in Engineering, Chemistry, Microbiology or Biology (required).
• 4–7+ years in equipment/utility qualification, process validation or related fields.
• Experience with cGMP and regulatory expectations is preferred.
• Excellent written and verbal communication skills and attention to detail.

Responsabilités

• Lead qualification and validation packages (IQ/OQ/PQ) for equipment, systems, utilities and facilities.
• Evaluate validation approaches for development, production and holding stages.
• Review test results and maintain records for analysis.
• Lead investigations and CAPA related to validation activities.
• Coordinate validation activities with clients and meet timelines.
• Mentor junior staff and travel to client sites as needed.

Connaissances

Problem solving

Technical writing

MS Office

Verbal communication

Troubleshooting

Formation

BS in technical discipline

Outils

Kaye validator

Wireless data loggers

Monitoring devices

Statistical tools

Description du poste

Quality Agents, LLC seeks a Senior Consultant to lead technical work streams and mentor junior staff in qualification and validation projects for pharmaceutical equipment, utilities, and facilities. You will ensure compliance with cGMP expectations and coordinate with clients on validation strategies.

Travel to client sites is required to support qualification activities and ensure on-time delivery. Strong technical writing and data analysis skills are essential for success in this role.