Commissioning and Qualification (C&Q) Specialist

Inteldot • Gurabo, PR

2d • Onsite

About The Position

The C&Q Specialist is responsible for supporting and executing commissioning and qualification activities for capital projects within a regulated pharmaceutical manufacturing environment. This role ensures that equipment, systems, and facilities are installed, tested, and verified in compliance with GMP, regulatory requirements, and company standards. The C&Q Specialist develops and executes protocols, supports equipment testing, documents results, and ensures data integrity throughout all commissioning and qualification activities.

Requirements

• Bachelor’s degree in science or engineering field with a minimum of 2 years of experience in commissioning and qualification, or bachelor’s degree in business administration with a minimum of 3 years of experience in commissioning and qualification processes.
• Experience developing and executing C&Q protocols in a regulated pharmaceutical or biotechnology environment.
• Knowledge of GMP requirements and regulatory expectations (FDA, EMA, and applicable guidelines).
• Experience participating in FAT and SAT activities for manufacturing or facility equipment.
• Understanding of data integrity principles, including ALCOA+.
• Strong documentation, communication, and field execution skills.
• Bilingual (Spanish and English).

Nice To Haves

• Experience in pharmaceutical manufacturing, packaging, or cleanroom environments.
• Familiarity with validation lifecycle (commissioning, qualification, and handover).
• Experience working with engineering, QA, and vendor teams in capital project settings.
• Knowledge of calibration systems, utilities, and manufacturing equipment qualification.

Responsibilities

• Develop commissioning and qualification (C&Q) protocols and technical documentation in accordance with current industry standards and client requirements.
• Execute commissioning and qualification activities in the field across manufacturing, packaging, and facility systems.
• Support and participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new equipment and systems.
• Record test results accurately, legibly, and in compliance with ALCOA+ data integrity principles.
• Identify, document, and report deviations during testing activities and support root cause analysis.
• Propose corrective actions and participate in implementation and verification of resolved issues.
• Plan and coordinate required resources, including measurement devices, calibration equipment, and tooling for testing activities.
• Ensure compliance with site safety requirements, permits, and applicable regulatory and company policies during field execution.
• Collaborate with engineering, quality, validation, and vendor teams to ensure successful project delivery and system readiness.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level