Pharma C&Q Specialist — On-Site PR (Manatí)

Legalpmpartners; Barceloneta (PR); On-site; USD 90,000 - 150,000; Full time

Job summary

Legalpmpartners seeks a Commissioning & Qualification Specialist to support pharmaceutical facilities in the North Area of Puerto Rico (Manatí). You will lead IQ/OQ/PQ, CSV, startup and operational readiness for equipment, utilities, and manufacturing areas while ensuring regulatory compliance.

The ideal candidate has hands-on C&Q experience in sterile pharma environments, including autoclaves, HVAC, BAS, and electronic validation systems (ALM). Contract-based, on-site engagement with the client.

Qualifications

• Hands-on Commissioning & Qualification (C&Q) experience in pharma manufacturing.
• Experience with IQ/OQ/PQ protocols and CSV activities.
• Familiarity with sterile manufacturing environments and packaging areas.

Responsibilities

• Develop and execute IQ/OQ/PQ and qualification protocols for equipment, utilities, facilities and systems.
• Support commissioning of clean utilities, HVAC, BAS, autoclaves and related pharma systems.
• Prepare validation documentation with traceability and records in compliance with cGMP and FDA requirements.

Skills

C&Q expertise

Technical writing

Regulatory compliance

Cross-functional collaboration

ALM/electronic validation

Education

Bachelor's Degree in Engineering or Life Sciences

Tools

ALM

Honeywell BAS

Electronic validation systems

Job description

Legalpmpartners seeks a Commissioning & Qualification Specialist to support pharmaceutical facilities in the North Area of Puerto Rico (Manatí). You will lead IQ/OQ/PQ, CSV, startup and operational readiness for equipment, utilities, and manufacturing areas while ensuring regulatory compliance.

The ideal candidate has hands-on C&Q experience in sterile pharma environments, including autoclaves, HVAC, BAS, and electronic validation systems (ALM). Contract-based, on-site engagement with the client.