Pharma C&Q Validation Specialist

Pinnaql, Inc.; Gurabo (PR); On-site; USD 65,000 - 95,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a C&Q Specialist to support commissioning and qualification activities within regulated pharmaceutical and biotech environments.

You will develop and execute protocols, coordinate field execution, and ensure documentation aligns with GMP standards. The role requires collaboration with Engineering, Operations, Quality, contractors, and project teams, and involves field activities, equipment startup support, and compliance with data integrity

Qualifications

• Bachelor’s degree in a technical field is preferred.
• 2+ years of C&Q, validation, startup, or field execution experience for technical degrees.
• 3+ years of relevant experience for non-technical degrees."
• Experience in manufacturing systems, process equipment, or regulated infrastructure is preferred.
• Familiar with GMP, data integrity (ALCOA), and regulated documentation practices.

Responsibilities

• Support commissioning and qualification activities.
• Generate, review, and execute C&Q protocols and documentation.
• Support field execution activities and startup coordination.
• Participate in FAT & SAT activities, inspections, and field walkthroughs.
• Document test results in line with GMP and data integrity expectations.
• Coordinate with engineers, operations, quality, and vendors to support turnover.
• Assist with scheduling, meetings, and communication of issues and risks.
• Drive continuous improvement in commissioning, qualification, and documentation.

Skills

Verbal communication

Written communication

Organizational skills

Troubleshooting

Analytical thinking

Problem solving

Bilingual English/Spanish

Education

Bachelor’s degree in Engineering/Science/Business or related technical field

Tools

Kneat

Bluebeam

TrackWise

CMMS platforms

Job description

Validation & Engineering Group, Inc. is seeking a C&Q Specialist to support commissioning and qualification activities within regulated pharmaceutical and biotech environments.

You will develop and execute protocols, coordinate field execution, and ensure documentation aligns with GMP standards. The role requires collaboration with Engineering, Operations, Quality, contractors, and project teams, and involves field activities, equipment startup support, and compliance with data integrity