C&Q Specialist: GMP Validation & Startup Support

Pinnaql, Inc.; Puerto Rico; On-site; USD 70,000 - 100,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks a talented C&Q Specialist to support commissioning and qualification in regulated pharma/biotech environments in Puerto Rico.

The role focuses on protocol development, field execution, equipment startup support, and GMP documentation, coordinating with Engineering, Operations, Quality, contractors, vendors, and project teams to ensure operational readiness.

Qualifications

• Bachelor’s degree in Engineering, Science, Business Administration, or related technical field preferred.
• 2+ years in C&Q, validation, startup, or field execution for technical degrees.
• 3+ years relevant experience for non-technical degrees.
• Familiar with GMP docs, protocol execution, and data integrity.
• Experience with Kneat, Bluebeam, TrackWise, or CMMS systems is a plus.
• Excellent English and Spanish written and verbal communication.

Responsibilities

• Support commissioning and qualification activities for capital projects.
• Generate, review, and execute C&Q protocols and docs.
• Support field execution, verification, and readiness coordination.
• Participate in FAT/SAT, inspections, and startup support as required.
• Document test results and maintain GMP documentation practices.
• Track deviations, punch lists, corrective actions, and observations.
• Coordinate with Engineering, Operations, Quality, contractors, and vendors.
• Schedule and coordinate field activities and resource needs.
• Contribute to project meetings and status communications.
• Support continuous improvement in commissioning, qualification, and readiness.

Skills

Bilingual English/Spanish

Technical writing

Communication skills

Analytical problem-solving

Education

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

Tools

Kneat

Bluebeam

TrackWise

CMMS platforms

Job description

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks a talented C&Q Specialist to support commissioning and qualification in regulated pharma/biotech environments in Puerto Rico.

The role focuses on protocol development, field execution, equipment startup support, and GMP documentation, coordinating with Engineering, Operations, Quality, contractors, vendors, and project teams to ensure operational readiness.