C&Q Specialist — GMP Validation & Commissioning Lead

Pinnaql, Inc.; Humacao (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a C&Q Specialist to support commissioning and qualification activities for regulated pharmaceutical and biotechnology projects in Puerto Rico.

The role involves protocol development, field execution, startup support, and documentation coordination across Engineering, Operations, Quality, and vendors. The candidate will work on projects spanning manufacturing systems, process equipment, packaging, clean utilities, facilities, and automation systems,

Qualifications

• Bachelor’s degree in Engineering, Science, Business Administration, or related technical field preferred.
• Minimum of 2 years of relevant C&Q, validation, startup, or field execution experience.
• Candidates with Business Administration or other non-technical degrees should have a minimum of 3 years of relevant experience.
• Experience supporting manufacturing systems, process equipment, packaging systems, clean utilities, facilities, cleanrooms, automation systems, or regulated operational infrastructure.
• Familiarity with GMP, data integrity (ALCOA), and regulated documentation practices.
• Familiarity with Kneat, Bluebeam, TrackWise, CMMS platforms, or similar systems.
• Excellent English and Spanish communication, including technical writing.

Responsibilities

• Support assigned commissioning and qualification.
• Generate, review, and execute commissioning and qualification protocols and related technical documentation.
• Support field execution activities including commissioning support, verification activities, and operational readiness coordination.
• Participate in FAT & SAT activities, equipment inspections, field walkthroughs, and startup support.
• Support collection, review, and organization of commissioning and qualification documentation and test records.
• Document test results and execution activities per GMP and data integrity expectations.
• Coordinate with Engineering, Operations, Quality, contractors, vendors, and project teams to support execution and turnover.
• Support scheduling and coordination of field execution activities, testing activities, and resource needs.
• Participate in project meetings and communicate status, issues, risks, and actions.
• Support continuous improvement initiatives related to commissioning, documentation, and operational readiness.
• Ensure activities align with site procedures, GMP requirements, safety rules, and project expectations.

Skills

C&Q experience

Documentation skills

Regulatory knowledge

Bilingual English/Spanish

Education

Bachelor's degree in Engineering/Science/Business

Tools

Kneat

Bluebeam

TrackWise

CMMS platforms

Job description

Validation & Engineering Group, Inc. is seeking a C&Q Specialist to support commissioning and qualification activities for regulated pharmaceutical and biotechnology projects in Puerto Rico.

The role involves protocol development, field execution, startup support, and documentation coordination across Engineering, Operations, Quality, and vendors. The candidate will work on projects spanning manufacturing systems, process equipment, packaging, clean utilities, facilities, and automation systems,