C&Q Specialist: GMP Validation for Pharma Systems

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

Job summary

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

You will contribute to protocol development, field execution, startup support, and documentation coordination. Responsibilities span manufacturing systems, process equipment, clean utilities, and automation-related programs, with emphasis on GMP, data integrity (ALCOA), and

Qualifications

• Bachelor’s degree in Engineering, Science, Business Administration, or related technical field preferred.
• Minimum 2 years of C&Q, validation, startup, or field execution experience for technical degrees.
• Familiarity with GMP documentation, ALCOA data integrity, and regulated practices.
• Experience with Kneat/Bluebeam/TrackWise or similar systems preferred.

Responsibilities

• Support assigned commissioning and qualification protocols.
• Generate and execute QC/QA documentation and test records.
• Coordinate field execution activities and startup support.
• Participate in FAT & SAT activities and equipment inspections.
• Document results and deviations in GMP-compliant records.
• Coordinate with Engineering, Operations, Quality, and contractors.

Skills

Communication skills

Bilingual English/Spanish

GMP knowledge

Documentation expertise

Education

Bachelor's degree in Engineering, Science, Business Admin or related field

Tools

Kneat

Bluebeam

TrackWise

CMMS

Job description

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

You will contribute to protocol development, field execution, startup support, and documentation coordination. Responsibilities span manufacturing systems, process equipment, clean utilities, and automation-related programs, with emphasis on GMP, data integrity (ALCOA), and