C&Q Specialist — GMP Validation & Startup Expert

Pinnaql, Inc.; Juncos (PR); Sur place; USD 75 000 - 95 000; Plein temps

Résumé du poste

Validation & Engineering Group, Inc. is seeking a C&Q Specialist in Puerto Rico to support commissioning and qualification activities for regulated pharma/biotech manufacturing.

You will develop protocols, perform field execution, and coordinate with Engineering, Operations, Quality, contractors, and vendors. The role requires strong documentation, bilingual communication, and the ability to manage multiple field activities in a fast-paced, compliance-driven environment.

Qualifications

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

Responsabilités

• 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 activities as required.
• Support collection, review, and organization of commissioning and qualification documentation and test records.
• Document test results and execution activities in accordance with applicable GMP and data integrity expectations.
• Support identification, documentation, and follow-up of deviations, punch-list items, corrective actions, and technical observations during execution activities.
• Coordinate with Engineering, Operations, Quality, contractors, vendors, and project teams to support project execution and turnover activities.
• Support scheduling and coordination of field execution activities, testing activities, and resource needs.
• Participate in project meetings and support communication of execution status, technical issues, risks, and action items.
• Support continuous improvement initiatives related to commissioning, qualification, documentation, and operational readiness activities.
• Ensure commissioning and qualification activities are performed in alignment with applicable site procedures, GMP requirements, safety rules, policies and project expectations.

Connaissances

Bilingual EN/ES

Organizational skills

Analytical skills

Problem solving

Multitasking

Formation

Bachelor’s degree in engineering/science/business

Outils

Kneat

Bluebeam

TrackWise

CMMS

Description du poste

Validation & Engineering Group, Inc. is seeking a C&Q Specialist in Puerto Rico to support commissioning and qualification activities for regulated pharma/biotech manufacturing.

You will develop protocols, perform field execution, and coordinate with Engineering, Operations, Quality, contractors, and vendors. The role requires strong documentation, bilingual communication, and the ability to manage multiple field activities in a fast-paced, compliance-driven environment.