Inteldot has over 15 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Employment type: Full time and onsite role
Role Summary
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.
- 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.
- 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.
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Experience developing and executing C&Q protocols in a regulated pharmaceutical or biotechnology environment.
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Knowledge of GMP requirements and regulatory expectations (FDA, EMA, and applicable guidelines).
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Experience participating in FAT and SAT activities for manufacturing or facility equipment.
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Understanding of data integrity principles, including ALCOA+.
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Strong documentation, communication, and field execution skills.
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Bilingual (Spanish and English).
- 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.
